N/A
N=50
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Hip Osteoarthritis · Noninflammatory Degenerative Joint Disease · Avascular Necrosis · Correction of Functional Deformity · Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT03409666 ↗Enrolled (actual)
50
Serious AEs
4.4%
Results posted
Jul 2022
Primary outcome: Primary: Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) — 3.15; 3.90 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Taperloc Complete Microplasty stem (Device); Taperloc Complete Reduced Distal stem (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stability Over a Period of Two Year Measured by Migration With Röntgen Stereophotogrammetric Analysis (RSA) |
3.15; 3.90 | — |
| SECONDARY Difference in Surgical Positioning Between Taperloc Complete Reduced Distal and Taperloc Complete Microplasty |
0; 0; 0; 0; 2; 6 | — |
| SECONDARY Early Survival Assessed by Counting the Number of Implant Revisions |
0; 0 | — |
| SECONDARY Clinical Performance Measured by Clinician Based Outcome Sore Harris Hip Score (HHS) |
63.9; 65.1; 79.9; 82.4; 96.7; 95.7 | — |
| SECONDARY Clinical Performance Measured by Clinician Based Outcome Radiological Evaluation |
0; 0; 0; 0; 25; 21 | — |
| SECONDARY Clinical Performance Measured by Patient Based Outcome Using Hip Disability and Osteoarthritis Outcome Score (HOOS) |
94.2; 92; 89.8; 85.5; 92.7; 90.8 | — |
| SECONDARY Clinical Performance Measured by Patient Based Outcome EQ5D |
0.9; 0.9; 81.0; 81.0 | — |
| SECONDARY Clinical Performance Measured by Patient Based Outcome Using Oxford Hip Score (OHS) |
26.1; 25.6; 38.3; 37.5; 44.6; 43.1 | — |
| SECONDARY Clinical Performance Measured by Patient Based Outcome Forgotten Joint Score (FJS) |
47.8; 43.2; 69.9; 61.7; 72.3; 80.3 | — |
Summary
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA. Patients will be randomized in two arms, receiving a Taperloc Complete Reduced Distal or a Taperloc Complete Microplasty hip stem.
Eligibility Criteria
Inclusion Criteria
- Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
- Correction of functional deformity.
- Male or female
-≥ 18 and ≤ 70 years of age
- Subjects willing to return for follow-up evaluations.
- Subjects able to read and understand Dutch language.
Exclusion Criteria
- active Infection (or within 6 weeks after infection)
- Sepsis
- Osteomyelitis
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions
- diagnosed Osteoporosis or Osteomalacia
- Metabolic disorders which may impair bone formation
- Distant foci of infections which may spread to the implant site
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
Data sourced from ClinicalTrials.gov (NCT03409666). 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.