Aims

Systematic reviews of randomized controlled trials (RCTs) are the highest level of evidence used to inform patient care. However, it has been suggested that the quality of randomization in RCTs in orthopaedic surgery may be low. This study aims to describe the quality of randomization in trials included in systematic reviews in orthopaedic surgery.

Despite total knee arthroplasty demonstrating high levels of success, 20% of patients report dissatisfaction with their result. Wellness Stasis Socks are embedded with a proprietary pattern of neuro-receptor activation points that have been proven to activate a precise neuro-response, as according to the pattern theory of haptic perception, which stimulates improvements in pain and function. Technologies that manipulate this sensory environment, such as textured insoles, have proven to be effective in improving gait patterns in patients with knee osteoarthritis. In regard to patients undergoing TKA using this new technology may prove beneficial as an adjunct to recovery as many patients suffer from further deficits to their proprioceptive system caused by ligamentous damage and alterations to mechanoreceptors during procedure. We hypothesized that the Wellness Stasis Socks are a safe, cost-effective and easily scalable strategy to support TKA patients through their recovery. Double-blinded, placebo-controlled randomized trial. Randomization using a computer-generated program . All study coordinators, healthcare personel and patients were blinded to patient groups. All surgical procedures were conducted by the same technique and orthopaedic surgeon. Intervention group: Wellness Stasis socks containing receptor point-activation technology. Control group: indentical appearing Wellness Stasis socks without receptor point-activation technology. Sock use during the waking hours . All additional post-operative protocols remained consistent between groups including same facility physiotherapy . Additional modalities (ice machines, soft-tissue massages, acupuncture) were prohibited. WOMAC questionnaire completed at baseline, 2 weeks, and 6 weeks to assess pain, stiffness and physical function. G. *. Power software to determine minimum sample of 50 in each group. No patients were lost to follow up and all followed study protocol. Data analysis using SPSS software. P-values, effect sizes, and confidence intervals are reported to assess clinical relevance of the finding. Physical status classifications were compared using t-test. Within-subject and between-subject differences in the mean WOMAC were analyzed by ANOVA. Cramer's V statistical analysis noted that other variables of Sex, BMI, ASA classification and Age were not statistically different between the control and intervention groups. No statistical difference between groups in Preop Womac scores. The data showed a consistent improvement in Womac scores for pain and stiffness at 2 weeks post op in the interventional group over the control group. The womac scores assessing physical function showed a consistent improvement at both 2 and 6 weeks post op in the intervention group compared to the control group. There were no complications in either group associated the sock use. The intervention proved to be a low cost and safe additional intervention post operatively from TKA to help patients improve with regard to pain, stiffness and physical function. This study suggests this modality can be added to the list of other commonly used post op interventions such as cryocuffs, physiotherapy, and relaxation techniques as safe post op interventions to help patients improve post op TKA and can act as an adjunct in providing non narcotic pain control

Platelet Rich Plasma (PRP) has shown to be a general stimulation for repair and 1 year results showed promising success percentages. To determine the effectiveness of PRP compared with corticosteroid injections in patients with chronic lateral epicondylitis with a two-year follow-up. A double-blind randomized controlled trial was conducted between May 2006 and January 2008. The trial was conducted in two Dutch teaching hospitals. 100 patients with chronic lateral epicondylitis were randomly assigned to a leucocyte-enriched PRP group (n=51) or in the corticosteroid group (n=49). Randomization and allocation to the trial group were carried out by a central computer system. Patients received either a corticosteroid injection or an autologous platelet concentrate injection through a peppering needling technique. The primary analysis included Visual Analogue Scale (VAS) pain scores and Disabilities of the Arm, Shoulder, and Hand Outcome (DASH) scores. The PRP group was more often successfully treated than the corticosteroid group (p<.0001). Success was defined as a reduction of 25% on VAS or DASH scores without a re-intervention after 2 years. When baseline VAS and DASH scores were compared with the scores at 2 years follow-up, both groups significantly improved across time (intention-to-treat principle). However, the DASH scores of the corticosteroid group returned back to baseline levels, while the PRP significantly improved (as-treated principle). There were no complications related to the use of PRP. Treatment of patients with chronic lateral epicondylitis with PRP reduces pain and increases function significantly, exceeding the effect of corticosteroid injection even after a follow-up of two years. Future decisions for application of PRP for lateral epicondylitis should be confirmed by further follow-up from this trial and should take into account possible costs and harms as well as benefits

Despite a large body of literature the optimal choice of bearing surface for total hip arthoplasty (THA) remains controversial. To avoid the brittleness and squeaking noted with ceramic-on-ceramic and the metal ion release associated with metal-on-metal (MOM) articulations, a novel hybrid coupling of ceramic-on-metal (COM) has been introduced. The purpose of this study was to compare changes in serum metal ion levels and the functional performance of COM and MOM bearing combinations. Eighty-six patients (86 hips) undergoing THA between April 2009 and October 2010 were randomized to COM or MOM bearing couplings. All received identical uncemented acetabular shells and femoral components from two experienced surgeons using the same operative technique. Demographic and peri-operative data were recorded. Serum cobalt and chromium levels, renal function and disease specific outcome scores (Oxford Hip, Harris Hip, UCLA activity) were assessed at baseline, 6 and 12 months post-operatively. Patients and outcome assessors remained blinded. Mean age of the total cohort was 62.5 years. Randomization successfully matched groups for age, Body Mass Index, baseline serum Cobalt and Chromium levels, and pre-operative functional performance scores. One-year data is currently available for 25 of 44 COM and 26 of 42 MOM patients. No significant difference in serum cobalt (P value = 0.81) and chromium (P value = 0.66) levels between groups was noted. Improvements in outcome scores (Oxford Hip, Harris Hip, UCLA activity) were equivalent (P values 0.16 – 0.46). At 1-year, COM and MOM hip arthroplasty articulations appear equivalent in terms of function and serum metal ion levels. Data collection out to 5-years post-surgery continues

Purpose. This prospective, expertise-based randomized clinical trial compares arthroscopic to open shoulder stabilization by measuring the disease-specific quality of life outcome in patients with traumatic unidirectional anterior shoulder instability, and determining the incidence of recurrent instability at 2-years post-operatively. Method. One hundred and ninety-six patients were randomly allocated to arthroscopic (n=98) or open (n=98) repair using an expertise-based approach with a surgeon specializing in one type of surgery. Randomization was performed using computer-generation, variable block sizes and concealed envelopes. Outcomes were measured at baseline, 3 and 6 months, 1 and 2 years post-operatively. These outcomes included the Western Ontario Shoulder Instability (WOSI) Index quality of life outcome and the American Shoulder and Elbow Society (ASES) functional outcome. Both outcomes were measured on a visual analog scale from 0 to 100, where a higher score represents better quality of life or function. Recurrent instability was categorized as traumatic/atraumatic, and as a subluxation/dislocation. Analyses included ANOVA of repeated measures and independent t-tests. Bonferroni adjustments for pairwise contrasts were made for multiple comparisons. Chi-squared analyses were performed on recurrence. Statistical significance was reported at p < 0.05. Results. There were no statistically significant differences at baseline with respect to gender, involved dominant shoulders, age, WOSI or ASES scores. At 2-years post-operatively, 19 patients in the Open group and 14 patients in the Arthroscopic group were lost to follow-up. A comparison of the baseline characteristics of these lost to follow-up patients showed no statistically significant differences in WOSI and ASES scores, age, involved dominant shoulder, gender and presence of Hill Sachs lesions between the groups. Of the patients that completed 2-year follow-up, there was no difference in mean WOSI score between the two groups: Open = 85 (SD = 20; 95% CI = 81 89), Arthroscopic = 82 (SD = 20; 95% CI = 77 86), p = 0.31. The ASES score for the Open group at 2-years was 91 (SD = 13; 95% CI = 88 94) and 88 (SD = 16; 95% CI = 85 92) for the Arthroscopic group, p = 0.17. Recurrence rates at 2-years were statistically different with 11% in the Open (9/80) and 23% in the Arthroscopic (20/87) groups, p = 0.05. Conclusion. At 2-years post-operative follow-up, there was no difference in disease-specific quality of life between Open and Arthroscopic repair. Open repair had a significantly lower risk of recurrence

Background:. Total knee replacement (TKR) is a frequent and effective surgery for knee osteoarthritis. Postoperative pain is under concern and can be relieved by different methods, including femoral nerve block (FNB). The efficacy of FNB on pain relief was associated with the absence of clinical impact when measured with the range of motion (ROM). Recent studies suggest that the quadriceps strength is the best indicator of functional recovery after TKR. The goal of this study is to compare the quadriceps strength recovery after TKR according to the kind of analgesia (patient control analgesia (PCA) with or without FNB) Hypothesis: the FNB delays the QSR at short and mid-term follow-up. Methods:. Prospective randomized trial with single-blind assessment involving 135 patients admitted for TKR in an academic center. Randomization into one of the three following groups: A) Continuous FNB 48h + PCA B) Single-shot FNB and PCA C) PCA alone. Groups were comparable for demographic and surgical data. The FNB was realised and controlled (electric stimulation) by an expert anesthesiologist before the surgery. Follow-up standardised in all groups with blinded assessors. Quadriceps strength measured with a validated dynamometer at 6 weeks, 6 and 12 months. Secondary outcomes included clinical evaluation (ROM, pain, stability) and functional scores (SF-36 v2, WOMAC). Multivariate analysis (Kruskal-Wallis, Mann-Whitney) for main outcomes and Spearman factor for correlation. Sample size calculated for alpha 5% and study power 80%. Results:. 111 patients available for 6 weeks follow-up (A-B-C:40-38-33) and 104 (36-36-32) at 6 and 12 months. Two patients in group B excluded for direct fall in the first postoperative week with extensor mechanism rupture and peri-prosthetic femoral fracture. QSR is significantly decreased in patients with FNB at all times (mean, 95% IC): 6 weeks (A 51.3%, 44.1–58.5; B 62.2%, 55.2–69.2; C 77.4%, 70.7–84.1; p < 0,05), 6 months (A 65.4%, 57.9–72.9; B 82.1%, 74.2–90; C 95.7%, 88.5–102.9; p < 0,05) and 12 months (A 87.8%, 82.1–93.5; B 97.8%, 89–106.6; C 104.8%, 96.1–113.5; p < 0,05). No significant difference between continuous or single-shot FNB. Higher ROM in group C at all times (p 6 weeks = 0,046; p 6 months = 0,159; p 12 months = 0,026). No correlation between ROM and QSR (rho = 0,07; p = 0,23). Better functional results in the group C at all times (p < 0,05), with good correlation to QSR (rho = 0,177; p = 0,032). Slight difference in analgesic effect of FNB (p = 0,14). Conclusion:. Femoral nerve block has a negative influence on QSR at short and mid-term follow-up and delays the rehabilitation after TKR. QSR is actually the most sensitive indicator of functional recovery after TKR and is better related to functional tests than ROM. This can explain the harmlessness of FNB in previous studies. FNB should not yet be recommended for analgesia after TKR

It is unusual, if not unique, for three major research papers concerned with the management of the fractured neck of femur (FNOF) to be published in a short period of time, each describing large prospective randomized clinical trials. These studies were conducted in up to 17 countries worldwide, involving up to 80 surgical centers and include large numbers of patients (up to 2,900) with FNOF. Each article investigated common clinical dilemmas; the first paper comparing total hip arthroplasty versus hemiarthroplasty for FNOF, the second as to whether ‘fast track’ care offers improved clinical outcomes and the third, compares sliding hip with multiple cancellous hip screws. Each paper has been deemed of sufficient quality and importance to warrant publication in The Lancet or the New England Journal of Medicine. Although ‘premier’ journals, they only occationally contain orthopaedic studies and thus may not be routinely read by the busy orthopaedic/surgical clinician of any grade. It is therefore our intention with this present article to accurately summarize and combine the results of all three papers, presenting, in our opinion, the most important clinically relevant facts.

Cite this article: Bone Joint Open 2020;1-6:198–202.