Surgical reattachment of torn rotator cuff tendons can lead to satisfactory clinical outcome but failures remain common. Ortho-R product is a freeze-dried formulation of chitosan (CS) that is solubilized in platelet-rich plasma (PRP) to form injectable implants. The purpose of the current pilot study was to determine Ortho-R implant acute residency, test safety of different implant doses, and assess efficacy over standard of care in a sheep model.

The infraspinatus tendon (ISP) was detached and immediately repaired in 22 skeletally mature ewes. Repair was done with four suture anchors in a suture bridge configuration (n = 6 controls). Freeze-dried formulations containing 1% w/v chitosan (number average molar mass 35 kDa and degree of deacetylation 83%) with 1% w/v trehalose (as lyoprotectant) and 42.2 mM calcium chloride (as clot activator) were solubilized with autologous leukocyte-rich PRP and injected at the tendon-bone interface and on top of the repaired site (n = 6 with a 1 mL dose and n = 6 with a 2 mL dose). Acute implant residency was assessed histologically at 1 day (n = 2 with a 1 mL dose and n = 2 with a 2 mL dose). Outcome measures included MRI assessment at baseline, 6 weeks and 12 weeks, histopathology at 12 weeks and clinical pathology. MRI images and histological slides were scored by 2 blinded readers (veterinarian and human radiologist, and veterinarian pathologist) and averaged. The Generalized Linear Model task (SAS Enterprise Guide 7.1 and SAS 9.4) was used to compare the different groups with post-hoc analysis to test for pairwise differences.

Ortho-R implants were detected near the enthesis, near the top of the anchors holes and at the surface of ISP tendon and muscle at 1 day. Numerous polymorphonuclear cells were recruited to the implant in the case of ISP tendon and muscle. On MRI, all repair sites were hyperintense compared to normal tendon at 6 weeks and only 1 out 18 repair sites was isointense at 12 weeks. The tendon repair site gap seen on MRI, which is the length of the hyperintense region between the greater tuberosity and tendon with normal signal intensity, was decreased by treatment with the 2 mL dose when compared to control at 12 weeks (p = 0.01). Histologically, none of the repair sites were structurally normal. A trend of improved structural organization of the tendon (p = 0.06) and improved structural appearance of the enthesis (p = 0.1) with 2 mL dose treatment compared to control was seen at 12 weeks. There was no treatment-specific effect on all standard safety outcome measures, which suggests high safety.

Ortho-R implants (2 mL dose) modulated the rotator cuff healing processes in this large animal model. The promising MRI and histological findings may translate into improved mechanical performance, which will be assessed in a future study with a larger number of animals. This study provides preliminary evidence on the safety and efficacy of Ortho-R implants in a large animal model that could potentially be translated to a clinical setting.

Patellar tendinosis (PT) is common and can result in prolonged disability, especially in jumping athletes. Recently developed ultra-short-echo (UTE) MRI sequences allow for quantitative evaluation of tendon biostructure with T2* relaxometry. This study evaluated the relationships between changes over time (COT) in quantitative T2*-metrics, qualitative PT grades, and patient reported symptoms within 10 male basketball players from a single collegiate basketball team. All subjects completed weekly VISA-P symptomology questionnaires over the basketball season. Bilateral 3-Tesla MRIs (GE Healthcare) were obtained at pre- and post-season study visits. High-resolution, PD-weighted, FSE sequences were used to qualitatively grade PT. Quantitative T2*-metrics were evaluated using high-resolution, 3D, multi-echo, UTE-MRI sequences. Bilinear exponential fits of SI to corresponding echo time were used to calculate T2*-metrics. All qualitative and quantitative evaluations were region specific (proximal, middle, distal). Linear mixed effects models assessed associations of side and region with T2*-metrics. Spearman correlations evaluated relationships between outcome measures. Within and between study visits, significant side-to-side differences in T2*-metrics were found and were significantly impacted by leg dominance (p<0.05). Pre-season T2*-metrics correlated with COT in T2*-metrics, COT in T2*-metrics correlated with COT in qualitative PT grades, and post-season T2*-metrics correlated with max changes in VISA-P scores (ρ≥0.64). Quantitative T2*-metrics can detect PT and may be capable of predicting the onset of pathology. T2*-metrics could benefit the clinical management of PT: it is sensitive to changes in pathologic severity over time, and therefore can serve as a quantitative metric to guide treatment and evaluate intervention efficacy.

Introduction

The current recommendation by the AAOS in the 2010 clinical practice guidelines for the use of MRI to diagnose a periprosthetic joint infection (PJI) is “inconclusive” given the lack of evidence to support its use. The purpose of this study was to determine the utility of MRI with metal reduction artifact sequencing in diagnosing a periprosthetic joint infection (PJI) after total hip arthroplasty (THA).

Introduction

The current recommendation by the AAOS in the 2010 clinical practice guidelines for the use of MRI to diagnose a periprosthetic joint infection (PJI) is “inconclusive” given the lack of evidence to support its use. The purpose of this study was to determine the utility of MRI with metal reduction artifact sequencing in diagnosing a periprosthetic joint infection (PJI) after total hip arthroplasty (THA).

Introduction:

The earliest evidence of particle-induced response is found in the synovium, leading to osteolytic defect. The degree of synovitis can be quantified by magnetic resonance imaging (MRI). This is the first long-term, prospective, matched-pair study using MRI to analyze wear-induced synovitis and osteolysis between rotating-platform posterior-stabilized (RP-PS), fixed-bearing metal-back (FB-MB), and all-polyethylene tibial (APT) designs in active patients with identical femoral components and polyethylene.

Introduction: Computer-based wear analysis is currently the most accurate method for determining the in vivo wear rates of polyethylene liners during total hip arthroplasty. MRI of a total hip is emerging as the best method for determining the intra-articular volume of particulate debris. The purpose of this study is to determine if there is a correlation between polyethylene wear and the development of particle load in patients with highly crosslinked (HXLP) liners.

Materials and Methods: 20 well-functioning total hips (7 metal heads against HXLP liners and 13 ceramic heads against HXLP liners) in 18 young active individuals were analyzed using the following criteria: femoral head penetration of the liner was measured by Roman (ROntgen Monographic ANalysis) software and particulate load was calculated by MRI criteria as described by Potter et al. Clinical and radiographic analyses were performed using HSS, WOMAC, and criteria defined by DeLee, Charnley, and Engh. The average age of the patients was 57 (Range 45–67) and average follow-up was 1.6 y (range 1.0 – 3.0 y).

Results: All implants appeared well osteointegrated with no radiographic evidence of osteolysis. All patients had well-functioning total hips with a greater than one mile daily walking tolerance. A trend towards correlation was observed between increased polyethylene wear and increased particulate volumes. Average HXLP wear was 0.03 mm (range −0.19 to 0.27 mm) and average particle volume was 841 (range 6951 to 0). One patient in particular recorded 0.27 mm of polyethylene wear, mild particle disease and a particle disease volume of 3321 at 1.6 years follow-up. However, statistical significance could not be achieved with these data points.

Conclusions: There appears to be a relationship between polyethylene wear as measured by computer-based systems and particulate volume as measured by MRI. Limitations of the current methodology include the inability of computer-based systems to detect precise levels of minimal wear with HXLP liners, and the highly sensitive MRI images which may be detecting more than just wear debris.

The ability of optimised MRI to detect periarticular bony and soft tissue pathology in the post-arthroplasty hip is well documented; specifically it is able to detect early stages of particle disease well before osteolysis is apparent on radiographs. This is a prospective study designed to utilise MRI for the detection of early particle disease in asymptomatic patients after total hip arthroplasty.

Patients who underwent routine non-cemented THA were recruited from three different groups: metal-on-polyethylene, ceramic-on-ceramic, and ceramic-on-polyethylene bearing surfaces. All patients enrolled underwent optimised MRI one to three years (mean 1.7) after the index procedure. Images were analyzed for the presence of synovial proliferation, fibrous membrane formation or osteolysis. Particle disease was correlated with type of bearing surface, pain, activity level, patient satisfaction, and clinical outcome scales.

Thirty-two hips have been enrolled in the study to date. Early particle disease was seen in two of seven metal-on-polyethylene hips (29%), four of twelve ceramic-on-ceramic hips (33%), and six of thirteen ceramic-on-polyethylene hips (46%). Focal osteolysis was seen in one patient with a ceramic-on-polyethylene hip. These values were not statistically significant among the groups. The presence of early particle disease did not correlate with pain, activity level, patient satisfaction, or other clinical outcome scales.

This study allows patients with a well functioning total hip arthroplasty to be prospectively followed with MRI. It is the first to document the natural history of particle disease in vivo and considerably enhances our knowledge of periarticular pathology in the post-operative hip. These results demonstrate early particle disease is relatively common yet asymptomatic; they do not demonstrate advantages of any bearing couple over another for protection against particle disease at short-term follow-up.

We previously reported no clinical differences in short-term results in 26 patients that underwent fixed-bearing (FB) total knee arthroplasty in one knee followed by a rotating-platform (RP) version of the same implant in the contralateral knee at a later date. This study presents intermediate-term results in this unique cohort and uses optimised MRI for detection of particle disease in both knees.

Patients from the original series were asked to complete questionnaires regarding both knees. In addition, both knees were evaluated with optimised MRI, which has been shown to be useful in evaluating early particle disease and osteolysis before its appearance on radiographs.

Nine patients have been enrolled to date. At an average follow-up of 8.3 years for the FB side and 6.5 years for the RP side, no significant differences were found with respect to knee preference, pain, or overall satisfaction. Seven patients underwent MRI studies of both knees. Two FB knees demonstrated a massive intracapsular burden of particle disease (average 3066 mm3) with reactive synovitis, compared to no obvious particle disease in any RP knees. Osteolysis was seen around the femur in one FB knee and around the patella in two FB knees, compared to only around a single patella in the RP side.

RP knees continue to demonstrate excellent patient satisfaction that is comparable to clinical results of the FB design; however, FB knees demonstrate higher rates of particle disease and early osteolysis on MRI. This is the first study to demonstrate in vivo advantages of RP over FB designs. It is unclear whether this is due to the slightly longer follow-up period for the FB knees or a decreased wear rate in the RP design; these differences may become apparent with longitudinal follow-up.