Status:
COMPLETED
Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
Lead Sponsor:
DePuy International
Conditions:
Arm Injuries
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Primary Endpoints: Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of: * Functional recovery (patient-based) - using the O...
Eligibility Criteria
Inclusion
- Male or female subjects, aged 40 and above.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom 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 whose clinical symptoms and diagnosis suggest that they have a full-thickness rotator cuff tear (which includes but is not limited to the supraspinatus), which is degenerate in nature.
Exclusion
- Subjects who, in the opinion of the Investigator, have an existing condition that would prevent them from fulfilling the requirements of the Clinical Investigation Plan. (This should be detailed in the Screening Log.)
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical study with an investigational product in the last 6 months.
- Subjects who are currently known to be involved in any injury litigation claims relating to the shoulder being treated as part of the study.
- Subjects with a known allergy to porcine material or who, for religious or other reasons, are unwilling to accept a porcine-derived implant.
- Subjects who have undergone previous shoulder surgery (excluding purely-diagnostic arthroscopy).
- Subjects with significant paralysis of the shoulder.
- Subjects with inflammatory arthropathies.
- Subjects with active joint or systemic infection.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00208338
Start Date
July 1 2005
End Date
April 1 2015
Last Update
July 4 2016
Active Locations (2)
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1
U.Z. Gasthuis Berg
Leuven, Belgium, B-3000
2
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP