Trials / Completed
CompletedNCT03409666
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A total of 50 patients will be enrolled into the study, randomized 1:1. All patients will receive a G7 limited hole acetabular cup with E1 liner. All potential study subjects will be required to participate in the Informed Consent process.
Conditions
- Hip Osteoarthritis
- Noninflammatory Degenerative Joint Disease
- Avascular Necrosis
- Correction of Functional Deformity
- Rheumatoid Arthritis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Taperloc Complete Microplasty stem | Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner |
| DEVICE | Taperloc Complete Reduced Distal stem | Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner |
Timeline
- Start date
- 2017-05-12
- Primary completion
- 2020-11-06
- Completion
- 2020-11-06
- First posted
- 2018-01-24
- Last updated
- 2022-07-14
- Results posted
- 2022-07-14
Locations
1 site across 1 country: Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03409666. Inclusion in this directory is not an endorsement.