Status:
TERMINATED
PMCF Study of the CLS Brevius Stem With Kinectiv Technology
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
This study is a multi-center, prospective, non-controlled post-market surveillance study. The primary objective of this study is to confirm the safety and performance of the CLS Brevius stem with Kine...
Detailed Description
The CLS Brevius Stem with Kinectiv Technology (also referred to as CLS Brevius Kinectiv Stem) is a straight, cementless stem which is based on the successful anchoring philosophy of the CLS Spotorno S...
Eligibility Criteria
Inclusion
- Patient is 18 years of age minimum.
- Patient is suffering from severe hip pain and disability requiring primary unilateral or bilateral total hip arthroplasty based on physical exam and medical history.
- Patient is willing and able to cooperate in the required post-operative therapy.
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
- Patient has participated in the Informed Consent process and has signed the Ethics Committee approved 'Informed Consent'.
Exclusion
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis etc.) or femoral and/or acetabular osteosynthesis of the affected hip joint(s).
- Patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcoholic or drug abuser, anticipated to be non-compliant
- Acute, chronic local or systemic infections.
- Severe muscular, neural or vascular diseases that endanger the success of the procedure.
- Lack of bony structures proximal or distal to the joint, so that good anchorage of the implant is unlikely or impossible.
- Total or partial absence of the muscular or ligamentous apparatus.
- Any concomitant diseases that can jeopardize the functioning and the success of the implant.
- Allergy to the implanted material, above all to metal (e.g. Vanadium).
- Local bone tumors and/or cysts.
- Pregnancy.
- Skeletal immaturity.
Key Trial Info
Start Date :
January 7 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 14 2020
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT03410940
Start Date
January 7 2011
End Date
December 14 2020
Last Update
December 17 2020
Active Locations (4)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
2
Istituto Ortopedico Galeazzi
Milan, Italy, 20161
3
SPSK im. Prof. A. Grucy
Otwock, Poland, 05-400
4
HUA Santiago
Vitoria-Gasteiz, Spain, 01004