Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

Study Overview
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Brief Summary
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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 results collected will be used to clinically confirm the performance and safety of the LINK® SP-CL® Hip Prosthesis Stem in terms of the manufacturer's obligation to perform a PMCF. Furthermore the results can be used for future regulatory processes if needed.

Detailed Description
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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 performance issues under routine conditions [2,3]. Against this background a prospective multi-center outcome study of the LINK® SP-CL® is planned.

Official Title
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Prospective Clinical 5-year Follow-up of the LINK® SP-CL® Hip Prosthesis Stem

Conditions
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Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem Survival Rate | The survival of the stem | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate | Number and kind of complications | Up to 5 years | 
| Reoperation Rate | number of reoperations | Up to 5 years | 
| Harris Hip Score (HHS) | Clinical Score to get information about the subjects pain and hip function, collected continuously | Up to 5 years | 
| Oxford Hip Score (OHS) | PROM to assess function and pain after THR | Up to 5 years | 
| Forgotten Joint Score (FJS) | awareness of the artificial joint | Up to 2 years | 
| Mid Thigh Pain | Pain occuring in the front and mid part of the femur | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PMCF, Post Market Clinical Follow up, SP-CL, anatomic stem