Joint wear Osteoarthritis
Conditions
Interventions
None listed
Sponsors
Zimmer Biomet
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male and non-pregnant females : >= 18 years and <= 70 years 2. Patients requiring primary THR, suitable for the use of the GTS stem. 3. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis. 4. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule. 5. ASA classification score I-III. 6. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery. 7. Surgical technique is planned to be Anterior Supine Intramuscular (ASI), or patient has already received a GTS hip on the contralateral side.
Exclusion criteria
Exclusion criteria: 1. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study). 2. Patients who had a THA on contralateral side less than 6 months ago. 3. Patients with a major surgical procedure during the 12 weeks before the study-related operation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Harris Hip Score (HHS) at 2 years postoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| -Radiographic evaluation: stability, incidence of radiolucencies around the prosthesis and bone remodeling - Patient satisfaction: EQ5D quality of life - Adverse Events/Complications (including revisions/removals). - Survivorship | — |
Countries
Netherlands
Outcome results
None listed