Status:
COMPLETED
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Lead Sponsor:
Zimmer Biomet
Conditions:
Hip Osteoarthritis
Noninflammatory Degenerative Joint Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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, receivi...
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 part...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03409666
Start Date
May 12 2017
End Date
November 6 2020
Last Update
July 14 2022
Active Locations (1)
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1
Bravis
Roosendaal, Netherlands