Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Stem Survival Rate | The survival of the stem | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Number and kind of complications | Up to 5 years |
| Reoperation Rate | number of reoperations | Up to 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients with mobility-limiting disease, fracture or defect of the hip joint requiring primary THA with SP-CL® (i.e. primary or secondary coxarthrosis, osteoarthritis, femoral neck fracture, necrosis of the femoral head)
·
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thorsten Gehrke, Prof. Dr. | HELIOS Endo-Klinik Hamburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Barmherzige BrĂ¼der Regensburg | Regensburg | Bavaria | 93049 | Germany | ||
| HELIOS ENDO-Klinik |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D005271 | Femur Head Necrosis |
| D005265 | Femoral Neck Fractures |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Hamburg |
| 22767 |
| Germany |
| L'Istituto Ortopedico Gaetano Pini | Milan | 1-20122 | Italy |
| Hospital Sant Rafael | Barcelona | 08035 | Spain |
| D012216 |
| Rheumatic Diseases |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |