N/A
N=197
Allofit® IT With HXPE in Total Hip Arthroplasty
Avascular Necrosis · Osteoarthritis, Hip · Inflammatory Arthritis · Post-Traumatic Osteoarthritis of Hip
Bottom Line
View on ClinicalTrials.gov: NCT03672929 ↗Enrolled (actual)
197
Serious AEs
26.4%
Results posted
Jan 2026
Primary outcome: Primary: Survival of the Implant System — 89 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival of the Implant System |
89 | — |
| SECONDARY Safety of the Implant System |
33 | — |
| SECONDARY Harris Hip Score (HHS) |
51.5; 92.3; 94.4; 97.1; 96.6; 96.3 | — |
| SECONDARY EQ-5D-3L Score |
0.4; 0.9; 0.9; 0.9; 0.9; 0.9 | — |
| SECONDARY EQ-5D VAS |
52.7; 73.1; 78.4; 82.3; 82.1; 83.2 | — |
| SECONDARY Oxford Hip Score |
21.4; 41.1; 43.2; 44.8; 45.1; 45.5 | — |
| SECONDARY UCLA Activity Score |
4.3; 5.8; 6.0; 6.7; 6.7; 6.7 | — |
| SECONDARY Radiographic Evaluations - Acetabular Site |
0; 1; 0; 6; 188; 1 | — |
| SECONDARY Radiographic Evaluations - Femoral Side |
0; 6; 5; 3; 0; 0 | — |
Summary
The study design is a multi-center, prospective, non-controlled, consecutive cohort postmarket clinical follow-up study to obtain survival and outcome data on the Allofit IT Shell in combination with Longevity Liners in primary total hip arthroplasty.
Eligibility Criteria
Inclusion Criteria
- 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 (NCT03672929). 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.