Femoral Neck Fractures, Femur Head Necrosis, Osteoarthritis, Hip
Conditions
Keywords
PMCF, Post Market Clinical Follow up, SP-CL, anatomic stem
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 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
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.
Interventions
None listed
Sponsors
Waldemar Link GmbH & Co. KG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stem Survival Rate | Up to 5 years | The survival of the stem |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate | Up to 5 years | number of reoperations |
| Harris Hip Score (HHS) | Up to 5 years | Clinical Score to get information about the subjects pain and hip function, collected continuously |
| Complication Rate | Up to 5 years | Number and kind of complications |
| Forgotten Joint Score (FJS) | Up to 2 years | awareness of the artificial joint |
| Mid Thigh Pain | Up to 5 years | Pain occuring in the front and mid part of the femur |
| Oxford Hip Score (OHS) | Up to 5 years | PROM to assess function and pain after THR |
Countries
Germany, Italy, Spain
Outcome results
None listed