Study of Management of Large Bone Defects.
- Conditions
- Health Condition 1: T07- Unspecified multiple injuries
- Registration Number
- CTRI/2024/05/066962
- Lead Sponsor
- AO Innovation Translation Center (AO ITC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age = 18 years
2. Skeletally mature
3. Posttraumatic aseptic long bone defect > 2 cm in each cortex in humerus, femur or tibia, either
3a. initially after injury or
3b. after surgical debridement
4. Informed consent obtained, i.e.:
4a. Ability to understand the content of the patient information/ICF
4b. Willingness and ability to participate in the clinical investigation according to the registry plan
4c. Signed and dated EC/IRB approved written informed consent
OR
Written consent is provided according to the IRB/EC defined and approved procedures for patients who are not able to provide independent written informed consent
1. Any oblique defect that has less than 8 cm expansion when adding the defect size of all four cortices
2. Any not medically managed severe systemic disease
3. Pregnancy
4. Prisoners
5. Participation in any other medical device or medicinal product registry within the previous 3 months that could influence the results of the present registry
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome of management of post -traumatic long <br/ ><br>bones defects, To evaluate outcome and the quality of life after the treatment.Timepoint: 3 years enrollment period
- Secondary Outcome Measures
Name Time Method To describe patients characteristics and type of bone defect present, <br/ ><br>To evaluate the nature of the bone defect, induced by various causes, To describe surgical details and treatment modalities how the bone defect is treatedTimepoint: 36 months