A prospective study to evaluate long-term clinical outcomes of the GTS cementless femoral stem
- Conditions
- Joint wearOsteoarthritis10023213
- Registration Number
- NL-OMON55672
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
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.
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mean Harris Hip Score (HHS) at 2 years postoperative</p><br>
- Secondary Outcome Measures
Name Time Method <p>-Radiographic evaluation: stability, incidence of radiolucencies around the<br /><br>prosthesis and<br /><br>bone remodeling<br /><br>- Patient satisfaction: EQ5D quality of life<br /><br>- Adverse Events/Complications (including revisions/removals).<br /><br>- Survivorship</p><br>