Randomized controlled study comparing the Taperloc complete versus the Taperloc complete Microplasty.

Completed

Conditions: hip artrosis
hip wear
10023213

Registration Number: NL-OMON46938

Lead Sponsor: Zimmer Biomet Nederland BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

These are standard indications for usage of the Taperloc Complete and Taperloc Microplasty stem. ;Subjects with one of the following indications:
Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis and rheumatoid arthritis.
Correction of functional deformity. ;Additional inclusion criteria include:
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is migration at two year measured with RSA</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints are malalignment, incorrect sizing,<br /><br>subsidence and intraoperative fractures, early survival of the hip prosthesis<br /><br>at 2 year and Clinical performance based on the clinician based outcome (HHS<br /><br>and radiological evaluation) and the patient based outcomes (HOOS, EQ5D, Oxford<br /><br>Hip score, Forgotten Hip).<br /><br>One site will perform migration analysis with RSA. Migration at two year will<br /><br>be the primary endpoint for this sub-group.</p><br>