The effect of concentrated Blood and Bone Marrow Aspirate (cB+cBMA) in operative treatment of fifth metatarsal stress fractures
Withdrawn
- Conditions
- 10005944fatique fracturestress bone reactionstress fracture
- Registration Number
- NL-OMON38972
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
skeletally mature
stress fracture of fifth metatarsal on X-ray
Exclusion Criteria
*Expected non-compliance (patients who are unable to fill out questionnaires and cannot have them filled out)
*Patients participating in another clinical trial
*Patients suffering from auto-immune disease
*Patients receiving biologicals, prednisolon or some kind of chemotherapy < 1 year
*Concomitant painful or disabling disease of the lower limb
*No informed consent
*Pregnant and nursing women
*Active malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Radiological time to fracture union (in weeks)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- time to clinical union (weeks)<br /><br>- complication rate and safety<br /><br>- patient function and satisfaction (FAAM, AOFAS, SF36)<br /><br>- analysis of the composition of the aspirate (CD 34, CD 45, CD 105, CD 146, CD<br /><br>90, CD 271, CFU-F assay, absoluut aantal cellen, 7 AAD, qRT-PCR analyse)<br /><br>- analysis of the bone biopsions<br /><br>- eventually adjust the research protocol for the RCT phase (phase II)</p><br>