Status:
TERMINATED
Clinical Observation Study of the Hydroxylapatite-coated SL-PLUS™ Hip Shaft
Lead Sponsor:
Smith & Nephew Orthopaedics AG
Conditions:
Primary Total Hip Arthroplasty
Eligibility:
All Genders
18-75 years
Brief Summary
Summary from initial protocol Goal: Validation of the HA (hydroxylapatite) coated SL-PLUS™ stem within an observation study Study design: prospective, multicenter, observational, non-comparative stu...
Eligibility Criteria
Inclusion
- Primary total hip endoprosthesis of the side affected (unilateral or bilateral)
- Patient shall be provided with a HA-coated SL-PLUS™ stem
- Patient has no general medical contraindications regarding the surgery
- Signed informed consent form for the participation in the study
- X-ray examinations are possible
- Patient is willing to participate in the post-operative follow-up program
- Age: 18-75 years
Exclusion
- Previous failed hip joint surgery (endoprosthesis) of the side affected
- Previous infections in the joint affected; systemic infections
Key Trial Info
Start Date :
June 12 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 27 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04121585
Start Date
June 12 2009
End Date
October 27 2020
Last Update
June 1 2023
Active Locations (2)
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1
Orthopädie LKH Steyr
Steyr, Austria, 4400
2
Orthopädisches Krankenhaus Gersthof
Vienna, Austria, 1180