Comparison of early migration patterns between a ceramic and polyethylene liner in uncemented Trabecular Titanium cups: a 2-year randomized controlled trial of 52 hips using radiostereometric analysis.

BACKGROUND AND PURPOSE: Ceramic liners may reduce early stability of uncemented acetabular components due to higher stiffness. However, the bone ingrowth capacities of porous trabecular titanium might compensate for this effect. This prospective randomized trial quantifies migration patterns of the Delta-TT cup, and compares polyethylene and ceramic liners. PATIENTS AND METHODS: Patients undergoing primary uncemented total hip arthroplasty with the Delta-TT cup and femoral stem with ceramic head were randomized to a polyethylene (n = 25) or ceramic (n = 28) liner. Radiostereometric analysis (RSA) radiographs, patient-reported hip function (HOOS-PS, OHS), and quality of life (EQ5D) were collected at baseline and 1.5, 3, 6, 12, and 24 months postoperatively. Model-based RSA was used to calculate 3D cup translation and rotation, and mixed models were used to compare effects over time between groups. RESULTS: At 2 years follow-up, Delta-TT cups showed similar mean proximal translation of 0.56 mm (95% CI 0.38-0.75) in the ceramic (CE) group and 0.54 mm (0.30-0.77) in the polyethylene (PE) group, with a between group effect of 0.02 mm (-0.20-0.23). Most cup migration occurred in the first 1.5 to 3 months, stabilizing within 6 months. Any between-group effects were ≤ 0.30 mm for translation and ≤ 0.45° for rotation. Improvements in patient-reported hip function and quality of life were similar in both groups. INTERPRETATION: Regardless of liner type, Delta-TT cups showed some initial migration and stabilized within 6 months, which seems promising for long-term fixation in both cup-liner constructs.

Long Head of Biceps Tenotomy Is Not Inferior to Suprapectoral Tenodesis in Arthroscopic Repair of Nontraumatic Rotator Cuff Tears: A Multicenter, Non-inferiority, Randomized, Controlled Clinical Trial.

PURPOSE: To determine if long head of the biceps (LHB) tenotomy is not inferior to suprapectoral LHB tenodesis when performed in conjunction with arthroscopic repair of small- to medium-sized nontraumatic rotator cuff tears. METHODS: This multicenter, randomized, non-inferiority trial recruited 100 participants older than 50 years who had a supraspinatus and/or infraspinatus tear sagittally smaller than 3 cm and arthroscopically confirmed LHB pathology. During arthroscopic rotator cuff repair, we randomized 48 patients to undergo suprapectoral LHB tenodesis and 52 patients to undergo LHB tenotomy. Data were collected preoperatively and at 6 weeks, 3 months, and 1 year postoperatively. The primary outcome was non-inferiority of the Constant-Murley score (CMS) at 1-year follow-up. Secondary outcomes included the Dutch Oxford Shoulder Score; Disabilities of the Arm, Shoulder and Hand questionnaire; Popeye deformity; elbow flexion strength index; arm cramping pain; and quality of life (EQ-5D score). The integrity of the rotator cuff repair was assessed with magnetic resonance imaging. Differences between intervention groups were analyzed by mixed modeling. RESULTS: The mean CMS in the LHB tenotomy group improved from 44 (95% confidence interval [CI], 39-48) to 73 (95% CI, 68-79). In patients with LHB tenodesis, the mean CMS improved from 42 (95% CI, 37-48) to 78 (95% CI, 74-82). The difference between groups at 1-year follow-up was 4.8 (97.5% CI, -∞ to 11.4), with a P value for non-inferiority of .06. The secondary outcomes also improved over time, with no remarkable differences between groups. A Popeye deformity occurred in 33% of tenodesis patients and 47% of tenotomy patients (P = .17). Tenotomy was performed with a shorter operative time (73 minutes vs 82 minutes, P = .03). Magnetic resonance imaging showed a recurrent rotator cuff tear in 20% of all cases. CONCLUSIONS: Although statistically "inconclusive" regarding non-inferiority of the CMS at 1-year follow-up, any observed differences between patients with LHB tenotomy and those with LHB tenodesis in all outcome scores were small. LEVEL OF EVIDENCE: Level I, randomized controlled trial and treatment study.

Study protocol: Effectiveness of dual-mobility cups compared with uni-polar cups for preventing dislocation after primary total hip arthroplasty in elderly patients - design of a randomized controlled trial nested in the Dutch Arthroplasty Registry.

Background and purpose - Dislocation is the leading reason for early revision surgery after total hip arthroplasty (THA). The dual-mobility (DM) cup was developed to provide more stability and mechanically reduce the risk of dislocation. Despite the increased use of DM cups, high-quality evidence of their (cost-)effectiveness is lacking. The primary objective of this randomized controlled trial (RCT) is to investigate whether there is a difference in the number of hip dislocations following primary THA, using the posterolateral approach, with a DM cup compared with a unipolar (UP) cup in elderly patients 1 year after surgery. Secondary outcomes include the number of revision surgeries, patient-reported outcome measures (PROMs), and cost-effectiveness.Methods and analysis - This is a prospective multicenter nationwide, single-blinded RCT nested in the Dutch Arthroplasty Registry. Patients ≥ 70 years old, undergoing elective primary THA using the posterolateral approach, will be eligible. After written informed consent, 1,100 participants will be randomly allocated to the intervention or control group. The intervention group receives a THA with a DM cup and the control group a THA with a UP cup. PROMs are collected preoperatively, and 3 months, 1 and 2 years postoperatively. Primary outcome is the difference in number of dislocations between the UP and DM cup within 1 year, reported in the registry (revisions), or by the patients (closed or open reduction). Data will be analyzed using multilevel models as appropriate for each outcome (linear/logistic/survival). An economic evaluation will be performed from the healthcare and societal perspective, for dislocation and quality adjusted life years (QALYs).Trial registration - This RCT is registered at www.clinicaltrials.gov with identification number NCT04031820.