N/A
Completed N=234
Accolade® TMZF® Hip Stem Outcomes Study
Arthroplasty, Replacement, Hip
Source: ClinicalTrials.gov NCT00957658 ↗
Enrolled (actual)
234
Serious AEs
27.8%
Results posted
Aug 2014
Primary outcomePrimary: Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain — 98.85 percentage of hips — p=<.0001
Summary
The purpose of this study is to evaluate clinical and radiographic outcome data in patients implanted with the Accolade® TMZF® femoral stem.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Percentage (%) Cases Without Aseptic Loosening, Intraoperative Femoral Fracture or Thigh Pain |
98.85 | <.0001 sig |
| SECONDARY Percentage (%) of Hip Stems With Aseptic Loosening |
— | — |
| SECONDARY Revision/Removal Rates |
1.65; 2.84 | — |
| SECONDARY Change in Harris Hip Score (HHS) |
50.1; 89.4; 92.2 | <.0001 sig |
| SECONDARY Change in SF-12 Score |
32.3; 49.1; 45.6; 54.2; 44.8; 53.4 | <.0001 sig |
| SECONDARY Change in Lower Extremity Activity Scale (LEAS) Score |
8.4; 10.4; 10.2 | <.0001 sig |
| SECONDARY PEQ (Patient Expectation Questionnaire) Overall Satisfaction |
84.5; 88.4; 85.5; 89.9; 89.9; 91 | — |
| SECONDARY PEQ (Patient Evaluation Questionnaire) Percent Achievement |
42.6; 55.7; 47.0; 33.7; 28.9; 28.9 | — |
| SECONDARY Acetabular Insert Wear |
0.0342 | <.0001 sig |
| SECONDARY Wrist DXA Scan Analysis |
-0.4 | .0002 sig |
Eligibility Criteria
Inclusion Criteria
- Patient is a candidate for a primary total hip replacement.
- Patient has primary diagnosis of osteoarthritis (OA).
- Male and non-pregnant female patients ages 18 to 90.
- Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
- Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
Exclusion Criteria
- Patient has an active infection within the affected hip joint.
- Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
- Patient who is morbidly obese, Body Mass Index (BMI) > 40.
- Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
- Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
- Patient is a prisoner.
Data sourced from ClinicalTrials.gov (NCT00957658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.