Does a Monoblock Acetabular Component With a Ceramic Liner Cause More Pelvic Bone Loss Than a Conventional Modular Cementless Acetabular Component? A 2-Year Randomized Clinical Trial.

BACKGROUND: Ceramic-on-ceramic bearings permit the use of large femoral head size while maintaining a favorable effect on wear rates. However, because of increased device rigidity, periprosthetic bone quality could be negatively affected due to stress shielding. The purpose of this study is to assess pelvic periprosthetic bone remodeling around a monoblock ceramic-on-ceramic acetabular component compared to that around a conventional modular metal-on-polyethylene device. METHODS: Participants were randomized to receive hip replacement using either a porous-coated, modular metal-on-polyethylene acetabular component (n = 46) or a hydroxyapatite and titanium-coated monoblock shell with an integrated ceramic-on-ceramic bearing (n = 40). Radiographic assessments were completed preoperatively and postoperatively, and measurements of bone mineral density (BMD) using dual-energy X-ray absorptiometry with region free analysis were performed postoperatively and over 2-years of follow-up. RESULTS: There was no significant difference in BMD between the 2 groups at baseline or over the following 2 years. At follow-up, complete shell-to-bone contact without a radiolucent line was observed in 26 (67%) of the modular devices and in 37 (93%) of monoblock (P < .001). The modular device was an independent predictor of radiolucent lines (odds ratio 19.1, P = .007). No cases underwent revision surgery for acetabular loosening. CONCLUSION: Both the porous-coated modular and hydroxyapatite-coated monoblock acetabular components showed successful clinical results at short-term follow-up with no difference in pixel-level BMD. Using a large head monoblock device does not appear to be associated with an adverse effect on the local bone environment when compared to a modular device. NCT: NCT01558752.

Influence of Femoral Component Design on Proximal Femoral Bone Mass After Total Hip Replacement: A Randomized Controlled Trial.

BACKGROUND: In this randomized controlled trial (RCT), we compared bone remodeling and bone turnover between 2 total hip arthroplasty implants-the short, proximally porous-coated Tri-Lock Bone-Preservation Stem and a conventional, fully-coated Corail prosthesis-over a 2-year postoperative period. METHODS: Forty-six participants received the Tri-Lock prosthesis and 40 received the Corail prosthesis. At baseline, the 2 groups had similar demographics, proximal femoral bone mineral density (BMD), bone turnover markers, radiographic canal flare index, and patient-reported outcome measure (PROM) scores. Outcomes were measured at weeks 26, 52, and 104. RESULTS: Loss of periprosthetic bone, measured by high-sensitivity dual x-ray absorptiometry region-free analysis (DXA-RFA), was identified at the calcar and proximal-lateral aspect of the femur in both prosthesis groups (p < 0.05). However, the conventional prosthesis was associated with a smaller reduction in BMD compared with the bone-preservation prosthesis (p < 0.001). This effect was most prominent in the region of the femoral calcar and greater trochanter. A small gain in BMD was also identified in some areas, and this gain was greater with the conventional than the bone-preservation prosthesis (p < 0.001). The 2 groups had similar changes in bone turnover markers and improvement in PROM scores over the study period (p > 0.05). The adverse-event rate was also similar between the groups (p > 0.05). CONCLUSIONS: This RCT shows that prostheses intended to preserve proximal femoral bone do not necessarily perform better in this regard than conventional cementless designs. DXA-RFA is a sensitive tool for detecting spatially complex patterns of periprosthetic bone remodeling. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Effect of denosumab on osteolytic lesion activity after total hip arthroplasty: a single-centre, randomised, double-blind, placebo-controlled, proof of concept trial.

BACKGROUND: Osteolysis causes recurrent pain and disability after total hip arthroplasty. We investigated the effect of the human monoclonal antibody denosumab on osteolytic lesion activity in patients undergoing revision total hip arthroplasty surgery to show the biological proof of concept for a non-surgical treatment for the disease. METHODS: We did a phase 2, randomised, double-blind, placebo-controlled, proof of concept superiority trial at Sheffield Teaching Hospitals, Sheffield, UK. Eligible patients aged 30 years or older and scheduled for revision surgery for symptomatic, radiographically confirmed osteolysis were randomly allocated (1:1) to subcutaneous denosumab (60 mg single-dose) or placebo by an independent pharmacist using a random number table. The primary outcome was the between-group difference in osteoclast number per mm of bone surface of biopsies taken from the osteolytic membrane-bone interface at surgery 8 weeks later, measured by quantitative histomorphometry in all patients who underwent revision surgery. Adverse events were analysed in all randomly assigned participants. This trial is registered with the EU Clinical Trials Register (EudraCT 2011-000541-20). FINDINGS: Between Dec 12, 2012, and June 24, 2018, 51 patients were assessed for eligibility, of whom 24 were randomly assigned to study treatment. Two patients had their revision surgery cancelled for unrelated reasons, leaving 22 patients (ten in the denosumab group) for analysis of the primary outcome. There were 83% fewer osteoclasts at the osteolysis membrane-bone interface in the denosumab versus the placebo group (median 0·05 per mm [IQR 0·11] vs 0·30 mm [0·40], p=0·011). No deaths or treatment-related serious adverse events occurred. Seven adverse events, including one severe adverse event, occurred in four (36%) of 11 patients in the denosumab group. In the placebo group ten adverse events, including three severe adverse events, occurred in five (38%) of 13 patients. INTERPRETATION: To our knowledge, this is the first clinical trial of an investigational drug for osteolysis that shows tissue-specific biological efficacy. These results justify the need for future trials that target earlier-stage disease to test for clinical efficacy in reducing the need for revision surgery. FUNDING: Amgen.