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Bone & Joint Research
Vol. 10, Issue 3 | Pages 203 - 217
1 Mar 2021
Wang Y Yin M Zhu S Chen X Zhou H Qian W

Patient-reported outcome measures (PROMs) are being used increasingly in total knee arthroplasty (TKA). We conducted a systematic review aimed at identifying psychometrically sound PROMs by appraising their measurement properties. Studies concerning the development and/or evaluation of the measurement properties of PROMs used in a TKA population were systematically retrieved via PubMed, Web of Science, Embase, and Scopus. Ratings for methodological quality and measurement properties were conducted according to updated COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Of the 155 articles on 34 instruments included, nine PROMs met the minimum requirements for psychometric validation and can be recommended to use as measures of TKA outcome: Oxford Knee Score (OKS); OKS–Activity and Participation Questionnaire (OKS-APQ); 12-item short form Knee Injury and Osteoarthritis Outcome (KOOS-12); KOOS Physical function Short form (KOOS-PS); Western Ontario and McMaster Universities Arthritis Index-Total Knee Replacement function short form (WOMAC-TKR); Lower Extremity Functional Scale (LEFS); Forgotten Joint Score (FJS); Patient’s Knee Implant Performance (PKIP); and University of California Los Angeles (UCLA) activity score. The pain and function subscales in WOMAC, as well as the pain, function, and quality of life subscales in KOOS, were validated psychometrically as standalone subscales instead of as whole instruments. However, none of the included PROMs have been validated for all measurement properties. Thus, further studies are still warranted to evaluate those PROMs. Use of the other 25 scales and subscales should be tempered until further studies validate their measurement properties. Cite this article: Bone Joint Res 2021;10(3):203–217


Bone & Joint Open
Vol. 4, Issue 5 | Pages 338 - 356
10 May 2023
Belt M Robben B Smolders JMH Schreurs BW Hannink G Smulders K

Aims

To map literature on prognostic factors related to outcomes of revision total knee arthroplasty (rTKA), to identify extensively studied factors and to guide future research into what domains need further exploration.

Methods

We performed a systematic literature search in MEDLINE, Embase, and Web of Science. The search string included multiple synonyms of the following keywords: "revision TKA", "outcome" and "prognostic factor". We searched for studies assessing the association between at least one prognostic factor and at least one outcome measure after rTKA surgery. Data on sample size, study design, prognostic factors, outcomes, and the direction of the association was extracted and included in an evidence map.


Bone & Joint Open
Vol. 3, Issue 10 | Pages 832 - 840
24 Oct 2022
Pearson NA Tutton E Joeris A Gwilym SE Grant R Keene DJ Haywood KL

Aims

To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.

Methods

Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.


Bone & Joint 360
Vol. 11, Issue 5 | Pages 39 - 42
1 Oct 2022


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 519 - 528
1 Apr 2022
Perry DC Arch B Appelbe D Francis P Craven J Monsell FP Williamson P Knight M

Aims. The aim of this study was to inform the epidemiology and treatment of slipped capital femoral epiphysis (SCFE). Methods. This was an anonymized comprehensive cohort study, with a nested consented cohort, following the the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework. A total of 143 of 144 hospitals treating SCFE in Great Britain participated over an 18-month period. Patients were cross-checked against national administrative data and potential missing patients were identified. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants. Results. A total of 486 children (513 hips) were newly affected, with a median of two patients (interquartile range 0 to 4) per hospital. The annual incidence was 3.34 (95% confidence interval (CI) 3.01 to 3.67) per 100,000 six- to 18-year-olds. Time to diagnosis in stable disease was increased in severe deformity. There was considerable variation in surgical strategy among those unable to walk at diagnosis (66 urgent surgery vs 43 surgery after interval delay), those with severe radiological deformity (34 fixation with deformity correction vs 36 without correction) and those with unaffected opposite hips (120 prophylactic fixation vs 286 no fixation). Independent risk factors for avascular necrosis (AVN) were the inability of the child to walk at presentation to hospital (adjusted odds ratio (aOR) 4.4 (95% CI 1.7 to 11.4)) and surgical technique of open reduction and internal fixation (aOR 7.5 (95% CI 2.4 to 23.2)). Overall, 33 unaffected untreated opposite hips (11.5%) were treated for SCFE by two-year follow-up. Age was the only independent risk factor for contralateral SCFE, with age under 12.5 years the optimal cut-off to define ‘at risk’. Of hips treated with prophylactic fixation, none had SCFE, though complications included femoral fracture, AVN, and revision surgery. PROMs demonstrated the marked impact on quality of life on the child because of SCFE. Conclusion. The experience of individual hospitals is limited and mechanisms to consolidate learning may enhance care. Diagnostic delays were common and radiological severity worsened with increasing time to diagnosis. There was unexplained variation in treatment, some of which exposes children to significant risks that should be evaluated through randomized controlled trials. Cite this article: Bone Joint J 2022;104-B(4):519–528


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 855 - 863
1 May 2021
Koster LA Meinardi JE Kaptein BL Van der Linden - Van der Zwaag E Nelissen RGHH

Aims. The objective of this study was to compare the two-year migration pattern and clinical outcomes of a total knee arthroplasty (TKA) with an asymmetrical tibial design (Persona PS) and a well-proven TKA with a symmetrical tibial design (NexGen LPS). Methods. A randomized controlled radiostereometric analysis (RSA) trial was conducted including 75 cemented posterior-stabilized TKAs. Implant migration was measured with RSA. Maximum total point motion (MTPM), translations, rotations, clinical outcomes, and patient-reported outcome measures (PROMs) were assessed at one week postoperatively and at three, six, 12, and 24 months postoperatively. Results. A linear mixed-effect model using RSA data of 31 asymmetrical and 38 symmetrical TKAs did not show a difference in mean MTPM migration pattern of the tibial or femoral components. Mean tibial component MTPM at two years postoperative of the asymmetrical TKA design was 0.93 mm and 1.00 mm for the symmetrical design. For the femoral component these values were 1.04 mm and 1.14 mm, respectively. No significant differences were observed in other migration parameters or in clinical and PROM measurements. Conclusion. The TKA design with an asymmetrical tibial component has comparable component migration with the proven TKA with a symmetrical tibial component. This suggests the risk of long-term aseptic loosening of the two designs is comparable. Cite this article: Bone Joint J 2021;103-B(5):855–863


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1449 - 1456
1 Sep 2021
Kazarian GS Lieberman EG Hansen EJ Nunley RM Barrack RL

Aims. The goal of the current systematic review was to assess the impact of implant placement accuracy on outcomes following total knee arthroplasty (TKA). Methods. A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using the Ovid Medline, Embase, Cochrane Central, and Web of Science databases in order to assess the impact of the patient-reported outcomes measures (PROMs) and implant placement accuracy on outcomes following TKA. Studies assessing the impact of implant alignment, rotation, size, overhang, or condylar offset were included. Study quality was assessed, evidence was graded (one-star: no evidence, two-star: limited evidence, three-star: moderate evidence, four-star: strong evidence), and recommendations were made based on the available evidence. Results. A total of 49 studies were identified for inclusion. With respect to PROMs, there was two-star evidence in support of mechanical axis alignment (MAA), femorotibial angle (FTA), femoral coronal angle (FCA), tibial coronal angle (TCA), femoral sagittal angle (FSA), femoral rotation, tibial and combined rotation/mismatch, and implant size/overhang or offset on PROMs, and one-star evidence in support of tibial sagittal angle (TSA), impacting PROMs. With respect to survival, there was three- to four-star evidence in support FTA, FCA, TCA, and TSA, moderate evidence in support of femoral rotation, tibial and combined rotation/mismatch, and limited evidence in support of MAA, FSA, and implant size/overhang or offset impacting survival. Conclusion. Overall, there is limited evidence to suggest that PROMs are impacted by the accuracy of implant placement, and malalignment does not appear to be a significant driver of the observed high rates of patient dissatisfaction following TKA. However, FTA, FCA, TCA, TSA, and implant rotation demonstrate a moderate-strong relationship with implant survival. Efforts should be made to improve the accuracy of these parameters in order to improve TKA survival. Cite this article: Bone Joint J 2021;103-B(9):1449–1456


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1039 - 1046
1 Sep 2022
Özdemir E Kuijpers MFL Visser J Schreurs BW Rijnen WHC

Aims

The aim of this study is to report the long-term outcomes of instrumented femoral revisions with impaction allograft bone grafting (IBG) using the X-change femoral revision system at 30 years after introduction of the technique.

Methods

We updated the outcomes of our previous study, based on 208 consecutive revisions using IBG and the X-change femoral revision system in combination with a cemented polished stem, performed in our tertiary care institute between 1991 and 2007. Kaplan-Meier survival analyses were used to determine the survival rate of the revisions with endpoint revision for any reason and aseptic loosening. Secondary outcomes were radiological loosening and patient-reported outcome measures.


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1049 - 1056
1 Dec 2021
Shields DW Razii N Doonan J Mahendra A Gupta S

Aims. The primary objective of this study was to compare the postoperative infection rate between negative pressure wound therapy (NPWT) and conventional dressings for closed incisions following soft-tissue sarcoma (STS) surgery. Secondary objectives were to compare rates of adverse wound events and functional scores. Methods. In this prospective, single-centre, randomized controlled trial (RCT), patients were randomized to either NPWT or conventional sterile occlusive dressings. A total of 17 patients, with a mean age of 54 years (21 to 81), were successfully recruited and none were lost to follow-up. Wound reviews were undertaken to identify any surgical site infection (SSI) or adverse wound events within 30 days. The Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) score were recorded as patient-reported outcome measures (PROMs). Results. There were two out of seven patients in the control group (28.6%), and two out of ten patients in the intervention group (20%) who were diagnosed with a SSI (p > 0.999), while one additional adverse wound event was identified in the control group (p = 0.593). No significant differences in PROMs were identified between the groups at either 30 days (TESS, p = 0.987; MSTS, p = 0.951) or six-month (TESS, p = 0.400) follow-up. However, neoadjuvant radiotherapy was significantly associated with a SSI within 30 days of surgery, across all patients (p = 0.029). The mean preoperative modified Glasgow Prognostic Score (mGPS) was also significantly higher among patients who developed a postoperative adverse wound event (p = 0.028), including a SSI (p = 0.008), across both groups. Conclusion. This is the first RCT comparing NPWT with conventional dressings following musculoskeletal tumour surgery. Postoperative wound complications are common in this group of patients and we observed an overall SSI rate of 23.5%. We propose proceeding to a multicentre trial, which will help more clearly define the role of closed incision NPWT in STS surgery. Cite this article: Bone Jt Open 2021;2(12):1049–1056


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 265 - 273
1 Feb 2022
Mens RH Bisseling P de Kleuver M van Hooff ML

Aims. To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set. Methods. AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman’s analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index). Results. At baseline, 65 out of 144 patients (45%) reported numerical rating scale (NRS) back pain scores > 5. All PROMs significantly improved at two-year follow-up. Mean improvements in SRS-22r function (+ 1.2 (SD 0.6)), pain (+ 0.6 (SD 0.8)), and self-image (+ 1.1 (SD 0.7)) domain scores, and the SRS-22r total score (+ 0.5 (SD 0.5)), were clinically relevant. At two-year follow-up, 14 out of 144 patients (10%) reported NRS back pain > 5. Surgical site infections did not occur. Only one patient (0.7%) underwent revision surgery. Conclusion. Relevant improvement in functioning, condition-specific and health-related QoL, self-image, and a relevant decrease in pain is shown at two-year follow-up after fusion surgery for AIS, with few adverse events. Contrary to the general perception that AIS is a largely asymptomatic condition, nearly half of patients report significant preoperative back pain, which reduced to 10% at two-year follow-up. Cite this article: Bone Joint J 2022;104-B(2):265–273


Bone & Joint Open
Vol. 3, Issue 7 | Pages 589 - 595
1 Jul 2022
Joo PY Chen AF Richards J Law TY Taylor K Marchand K Clark G Collopy D Marchand RC Roche M Mont MA Malkani AL

Aims

The aim of this study was to report patient and clinical outcomes following robotic-assisted total knee arthroplasty (RA-TKA) at multiple institutions with a minimum two-year follow-up.

Methods

This was a multicentre registry study from October 2016 to June 2021 that included 861 primary RA-TKA patients who completed at least one pre- and postoperative patient-reported outcome measure (PROM) questionnaire, including Forgotten Joint Score (FJS), Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR), and pain out of 100 points. The mean age was 67 years (35 to 86), 452 were male (53%), mean BMI was 31.5 kg/m2 (19 to 58), and 553 (64%) cemented and 308 (36%) cementless implants.


Bone & Joint Open
Vol. 3, Issue 7 | Pages 529 - 535
1 Jul 2022
Wormald JCR Rodrigues JN Cook JA Prieto-Alhambra D Costa ML

Aims

Hand trauma accounts for one in five of emergency department attendances, with a UK incidence of over five million injuries/year and 250,000 operations/year. Surgical site infection (SSI) in hand trauma surgery leads to further interventions, poor outcomes, and prolonged recovery, but has been poorly researched. Antimicrobial sutures have been recognized by both the World Health Organization and the National Institute for Clinical Excellence as potentially effective for reducing SSI. They have never been studied in hand trauma surgery: a completely different patient group and clinical pathway to previous randomized clinical trials (RCTs) of these sutures. Antimicrobial sutures are expensive, and further research in hand trauma is warranted before they become standard of care. The aim of this protocol is to conduct a feasibility study of antimicrobial sutures in patients undergoing hand trauma surgery to establish acceptability, compliance, and retention for a definitive trial.

Methods

A two-arm, multicentre feasibility RCT of 116 adult participants with hand and wrist injuries, randomized to either antimicrobial sutures or standard sutures. Study participants and outcome assessors will be blinded to treatment allocation. Outcome measures will be recorded at baseline (preoperatively), 30 days, 90 days, and six months, and will include SSI, patient-reported outcome measures, and return to work.


Bone & Joint Open
Vol. 5, Issue 10 | Pages 937 - 943
22 Oct 2024
Gregor RH Hooper GJ Frampton C

Aims. The aim of this study was to determine whether obesity had a detrimental effect on the long-term performance and survival of medial unicompartmental knee arthroplasties (UKAs). Methods. This study reviewed prospectively collected functional outcome scores and revision rates of all medial UKA patients with recorded BMI performed in Christchurch, New Zealand, from January 2011 to September 2021. Patient-reported outcome measures (PROMs) were the primary outcome of this study, with all-cause revision rate analyzed as a secondary outcome. PROMs were taken preoperatively, at six months, one year, five years, and ten years postoperatively. There were 873 patients who had functional scores recorded at five years and 164 patients had scores recorded at ten years. Further sub-group analysis was performed based on the patient’s BMI. Revision data were available through the New Zealand Joint Registry for 2,323 UKAs performed during this time period. Results. Obese patients (BMI > 30 kg/m. 2. ) were 3.1 years younger than non-obese patients (BMI < 30 kg/m. 2. ) at the time of surgery (mean age of obese patients 65.5 years (SD 9.7) and mean age of non-obese patients 68.6 years (SD 10.1)). Preoperatively, obese patients tended to have significantly lower functional scores than non-obese patients, which continued at five and ten years postoperatively. At these timepoints, obese patients had significantly lower scores for most PROMs measured compared to non-obese patients. However, there was no significant difference in the improvement of any of these scores after surgery between obese and non-obese patients. There was no significant difference in revision rates between obese and non-obese patients at any time. All-cause revision rate for obese patients was 0.73 per 100 observed component years compared to 0.67 in non-obese patients at ten years. There was also no significant difference in the aseptic loosening rate between groups. Conclusion. Our study supports the use of UKAs in obese patients, with similar benefit and survival compared to non-obese patients at ten years


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 813 - 821
1 May 2021
Burden EG Batten TJ Smith CD Evans JP

Aims. This systematic review asked which patterns of complications are associated with the three reverse total shoulder arthroplasty (RTSA) prosthetic designs, as classified by Routman et al, in patients undergoing RTSA for the management of cuff tear arthropathy, massive cuff tear, osteoarthritis, and rheumatoid arthritis. The three implant design philosophies investigated were medial glenoid/medial humerus (MGMH), medial glenoid/lateral humerus (MGLH), and lateral glenoid/medial humerus (LGMH). Methods. A systematic review of the literature was performed via a search of MEDLINE and Embase. Two reviewers extracted data on complication occurrence and patient-reported outcome measures (PROMs). Meta-analysis was conducted on the reported proportion of complications, weighted by sample size, and PROMs were pooled using the reported standardized mean difference (SMD). Quality of methodology was assessed using Wylde’s non-summative four-point system. The study was registered with PROSPERO (CRD42020193041). Results. A total of 42 studies met the inclusion and exclusion criteria. Rates of scapular notching were found to be significantly higher in MGMH implants (52% (95% confidence interval (CI) 40 to 63)) compared with MGLH ((18% (95% CI 6 to 34)) and LGMH (12% (95% CI 3 to 26)). Higher rates of glenoid loosening were seen in MGMH implants (6% (95% CI 3 to 10)) than in MGLH implants (0% (95% CI 0 to 2)). However, strength of evidence for this finding was low. No significant differences were identified in any other complication, and there were no significant differences observed in PROMs between implant philosophies. Conclusion. This systematic review has found significant improvement in PROMS and low complication rates across the implant philosophies studied. Scapular notching was the only complication found definitely to have significantly higher prevalence with the MGMH implant design. Cite this article: Bone Joint J 2021;103-B(5):813–821


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 657 - 662
1 Jun 2022
Barlow T Coco V Shivji F Grassi A Asplin L Thompson P Metcalfe A Zaffagnini S Spalding T

Aims

Meniscal allograft transplantation (MAT) for patients with symptomatic meniscal loss has demonstrated good clinical results and survivorship. Factors that affect both functional outcome and survivorship have been reported in the literature. These are typically single-centre case series with relatively small numbers and conflicting results. Our aim was to describe an international, two-centre case series, and identify factors that affect both functional outcome and survival.

Methods

We report factors that affect outcome on 526 patients undergoing MAT across two sites (one in the UK and one in Italy). Outcomes of interest were the Knee injury and Osteoarthritis Outcome Score four (KOOS4) at two years and failure rates. We performed multiple regression analysis to examine for factors affecting KOOS, and Cox proportional hazards models for survivorship.


Bone & Joint 360
Vol. 10, Issue 5 | Pages 18 - 20
1 Oct 2021


Bone & Joint Open
Vol. 2, Issue 10 | Pages 858 - 864
18 Oct 2021
Guntin J Plummer D Della Valle C DeBenedetti A Nam D

Aims

Prior studies have identified that malseating of a modular dual mobility liner can occur, with previous reported incidences between 5.8% and 16.4%. The aim of this study was to determine the incidence of malseating in dual mobility implants at our institution, assess for risk factors for liner malseating, and investigate whether liner malseating has any impact on clinical outcomes after surgery.

Methods

We retrospectively reviewed the radiographs of 239 primary and revision total hip arthroplasties with a modular dual mobility liner. Two independent reviewers assessed radiographs for each patient twice for evidence of malseating, with a third observer acting as a tiebreaker. Univariate analysis was conducted to determine risk factors for malseating with Youden’s index used to identify cut-off points. Cohen’s kappa test was used to measure interobserver and intraobserver reliability.


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 536 - 541
1 Mar 2021
Ferlic PW Hauser L Götzen M Lindtner RA Fischler S Krismer M

Aims. The aim of this retrospective study was to compare the correction achieved using a convex pedicle screw technique and a low implant density achieved using periapical concave-sided screws and a high implant density. We hypothesized that there would be no difference in outcome between the two techniques. Methods. We retrospectively analyzed a series of 51 patients with a thoracic adolescent idiopathic scoliosis. There were 26 patients in the convex pedicle screw group who had screws implanted periapically (Group 2) and a control group of 25 patients with bilateral pedicle screws (Group 1). The patients’ charts were reviewed and pre- and postoperative radiographs evaluated. Postoperative patient-reported outcome measures (PROMs) were recorded. Results. The number of implants (14.5 vs 17.1) and the implant density (1.5 vs 1.9) were significantly lower in Group 2 (p < 0.001). Operating time was 27 minutes shorter in Group 2 than in Group 1, with a mean of 217 minutes (SD 50.5; 120 to 346). The duration of surgery per instrumented vertebra was reduced by 19% in Group 2 (p = 0.011). No statistical difference was found in the postoperative Cobb angle, vertebral rotation, the relative correction achieved, or postoperative PROMs. Conclusion. Despite a lower implant density and achieving correction through a convex rod, surgical correction of the Cobb angle and vertebral body rotation was similar in both groups. Periapical pedicle screws and primary correction on the concave side do not seem to be mandatory in order to achieve good surgical results in idiopathic thoracic scoliosis. The operating time was shorter in the group with lower implant density. In conclusion, the technique provided good results and has the potential to reduce complications and costs. Cite this article: Bone Joint J 2021;103-B(3):536–541


Bone & Joint Open
Vol. 3, Issue 5 | Pages 375 - 382
5 May 2022
Teunissen JS van der Oest MJW Selles RW Ulrich DJO Hovius SER van der Heijden B

Aims

The primary aim of this study was to describe long-term patient-reported outcomes after ulna shortening osteotomy for ulna impaction syndrome.

Methods

Overall, 89 patients treated between July 2011 and November 2017 who had previously taken part in a routine outcome evaluation up to 12 months postoperatively were sent an additional questionnaire in February 2021. The primary outcome was the Patient-Rated Wrist and Hand Evaluation (PRWHE) total score. Secondary outcomes included patient satisfaction with treatment results, complications, and subsequent treatment for ulnar-sided wrist pain. Linear mixed models were used to compare preoperative, 12 months, and late follow-up (ranging from four to nine years) PRWHE scores.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1599 - 1607
1 Dec 2020
Marson BA Craxford S Deshmukh SR Grindlay DJC Manning JC Ollivere BJ

Aims. This study evaluates the quality of patient-reported outcome measures (PROMs) reported in childhood fracture trials and recommends outcome measures to assess and report physical function, functional capacity, and quality of life using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) standards. Methods. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-compliant systematic review of OVID Medline, Embase, and Cochrane CENTRAL was performed to identify all PROMs reported in trials. A search of OVID Medline, Embase, and PsycINFO was performed to identify all PROMs with validation studies in childhood fractures. Development studies were identified through hand-searching. Data extraction was undertaken by two reviewers. Study quality and risk of bias was evaluated by COSMIN guidelines and recorded on standardized checklists. Results. Searches yielded 13,672 studies, which were screened to identify 124 trials and two validation studies. Review of the 124 trials identified 16 reported PROMs, of which two had validation studies. The development papers were retrieved for all PROMs. The quality of the original development studies was adequate for Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility and Upper Extremity and doubtful for the EuroQol Five Dimension Youth questionnaire (EQ-5D-Y). All other PROMs were found to have inadequate development studies. No content validity studies were identified. Reviewer-rated content validity was acceptable for six PROMs: Activity Scale for Kids (ASK), Childhood Health Assessment Questionnaire, PROMIS Upper Extremity, PROMIS Mobility, EQ-5D-Y, and Pediatric Quality of Life Inventory (PedsQL4.0). The Modified Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire was shown to have indeterminate reliability and convergence validity in one study and PROMIS Upper Extremity had insufficient convergence validity in one study. Conclusion. There is insufficient evidence to recommend strongly the use of any single PROM to assess and report physical function or quality of life following childhood fractures. There is a need to conduct validation studies for PROMs. In the absence of these studies, we cautiously recommend the use of the PROMIS or ASK-P for physical function and the PedsQL4.0 or EQ-5D-Y for quality of life. Cite this article: Bone Joint J 2020;102-B(12):1599–1607