Status:
TERMINATED
A Study to Evaluate the DePuy Minimally Invasive Unicompartmental Knee
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief Summary
The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting. T...
Detailed Description
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and com...
Eligibility Criteria
Inclusion
- Male or female subjects, who are 40 to 75 years of age inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom written consent has been obtained.
- Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who exhibit loss of articular cartilage which is predominantly confined to a single compartment. The remaining compartments must be intact and able to bear normal loads.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with the investigation device, according to the indications specified in the package insert leaflet.
Exclusion
- Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Subjects with a known history of poor compliance to medical treatment.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last month.
- Subjects who are currently involved in any injury litigation claims.
- Revision of an existing unicompartmental implant.
- Subjects who have gross ligament laxity / instability.
- Subjects who have an inflammatory joint disease
- Subjects in whom there is evidence of previous joint sepsis
- Subjects who have a pre-operative flexion contracture of 15° or greater
- Subjects who have a pre-operative flexion of less than 90°
- Subjects who have a pre-operative limb deformity of greater than 15° varus or valgus
- Subjects who have morbid obesity i.e. BMI \> 40%
Key Trial Info
Start Date :
June 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT00734084
Start Date
June 1 2001
End Date
April 1 2008
Last Update
June 9 2015
Active Locations (1)
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1
Sportsmed SA, 32 Payneham, Stepney
Adelaide, South Australia, Australia, 5069