The effect of concentrated bone marrowaspirate in operative treatment of fifthmetatarsal stress fractures

Conditions: stress fracture, stressfractuur, fifth metatarsal, vijfde os metatarsale, bone marrow, beenmerg, stem cells, stamcellen

Registration Number: NL-OMON19971

Lead Sponsor: Academic Medical Center (AMC) Amsterdam, Orthopaedic Research Center Amsterdam (ORCA) Department of Orthopaedics, The Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

MT-V stress fracture diagnosed on physical examination and X-ray
- Skeletally mature patients

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
Radiological time to fracture union in weeks

Secondary Outcome Measures

Name	Time	Method
Clinical time to union in weeks, time to return to sport and work or activities (in weeks), union rate (in %), patient function and satisfaction (SF-12, AOFAS, FAAM), complication rate, safety and cost-effectiveness. <br>Furthermore from all patients, a bone biopsy will be taken and analyzed to achieve<br>information of the stage of fracture healing at the time of operation. Also all obtained<br>cBMA will be analyzed in the laboratory and quality and osteogenic activity of the<br>aspirate is measured by means of CD34, CD45, CD90, CD105, CD146, CD271 count, CFUF assay and in a later stadium mRNA analysis. Patients characteristics (including foot type, shoe brand, age, weight, etc) are also recorded