NL-OMON55672RecruitingNot Applicable
A prospective study to evaluate long-term clinical outcomes of the GTS cementless femoral stem - H36 GTS international
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Zimmer Biomet
- Enrollment
- 23
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
Investigators
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