N/A
Completed N=185
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Avascular Necrosis of Hip · Osteoarthritis, Hip · Rheumatoid Arthritis · Post-Traumatic Osteoarthritis of Hip
Source: ClinicalTrials.gov NCT03672916 ↗
Enrolled (actual)
185
Serious AEs
24.3%
Results posted
Feb 2025
Primary outcomePrimary: Survivorship — 179 Implants
Summary
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survivorship |
179 | — |
| PRIMARY Safety of the Implant |
9; 6; 38 | — |
| SECONDARY Harris Hip Score |
48.8; 93.2; 96.1; 96.9; 96.1; 95.2 | — |
| SECONDARY EQ-5D |
0.4; 0.9; 0.9; 0.9; 0.9; 0.8 | — |
| SECONDARY SF-12 Physical and Mental Functional Scores |
28.8; 46.5; 48.5; 49.5; 47.0; 46.9 | — |
| SECONDARY UCLA Activity Score |
4.3; 6.1; 6.4; 6.6; 6.2; 6.4 | — |
| SECONDARY Radiographic Evaluations |
11; 4; 6; 1; 3; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is 18 to 75 years of age, inclusive.
- Patient is skeletally mature.
- Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
- Avascular necrosis (AVN)
- Osteoarthritis (OA)
- Inflammatory arthritis (i.e. Rheumatoid arthritis)
- Post-traumatic arthritis
- Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
- Patient has a Harris Hip Score 40.
Data sourced from ClinicalTrials.gov (NCT03672916). 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.