GAMMA3™INTERNATIONAL MULTICENTRE PROSPECTIVECLINICAL POST-MARKET FOLLOW-UP EVALUATIO
- Conditions
- Trochanteric fractureS72.10
- Registration Number
- DRKS00004593
- Lead Sponsor
- Stryker Osteosynthesis Clinical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 437
Male and female patients.
Patients of 50 years or older of age at time of surgery.
Patients who understand the conditions of the International Multicentre Prospective Clinical Follow-Up Evaluation and are willing and able to participate for the length of the prescribed term of follow-up.
Patients with the ability to walk prior to the accident, with or without walking aids.
Patients who have given a written consent (signed the Informed Consent form).
Patients, who as judged by the surgeon, are reasonably unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule,
Patients with a physical condition (e.g. severe obesity) or neuromuscular deficit that interferes with the patient’s ability to limit weight bearing or places an extreme load on the implant in the healing period.
Patients with other concurrent illnesses which are likely to affect their over all outcome.
Patients who have not given a written consent (signed the Informed Consent form).
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 12 Months Postoperative Evaluation (- 4 Weeks / + 6 Weeks):<br>• Merle d’Aubigne Score (pain, function, mobility & range of motion for both legs)
- Secondary Outcome Measures
Name Time Method