Status:
UNKNOWN
Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem
Lead Sponsor:
Waldemar Link GmbH & Co. KG
Conditions:
Osteoarthritis, Hip
Femur Head Necrosis
Eligibility:
All Genders
18-75 years
Brief Summary
The objective of this PMCF is to collect clinical and radiographic outcome information on Total Hip Arthroplasty (THA) performed with LINK® SP-CL® Hip Prosthesis Stem under routine conditions. The re...
Detailed Description
Post Market Clinical Follow-ups (PMCF) through observational studies are an important tool to detect infrequent complications or problems, events specific to defined patient populations and long term ...
Eligibility Criteria
Inclusion
- Skeletally mature
- Subject agrees to comply with the required postoperative management and follow-up evaluations
- Undergone at least six (6) month of unsuccessful, conservative, non-surgical treatment
- Patient understands the conditions of the study and is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations and the prescribed postoperative management.
- Patient signed Informed Consent.
Exclusion
- Body Mass Index (BMI) \> 40 kg/m2
- Poor general state of health
- Acute and chronic infections, local and systemic
- Pharmaceutical or other drug abuse, alcoholism
- Allergies to implant materials
- Distinctive muscular, nerve, vascular or other diseases which put the affected limb at risk
- Insufficient / inadequate bone mass- or quality which prevents a stable anchorage of the prosthesis
- Severe osteoporosis
- Foreseeable overload/ overstressing of the joint prosthesis
- Acetabular defects
- Female patient who is pregnant or plans to became pregnant during the course of the study
- Prisoner
- Patient who, as judged by the surgeon, is mentally incompetent or is unlikely to be compliant with the prescribed postoperative routine and follow-up evaluation schedule
- Patient who has not signed the Informed Consent
Key Trial Info
Start Date :
July 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02288117
Start Date
July 1 2015
End Date
May 1 2023
Last Update
December 19 2020
Active Locations (4)
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1
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, Bavaria, Germany, 93049
2
HELIOS ENDO-Klinik
Hamburg, Germany, 22767
3
L'Istituto Ortopedico Gaetano Pini
Milan, Italy, 1-20122
4
Hospital Sant Rafael
Barcelona, Spain, 08035