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The effect of concentrated Blood and Bone Marrow Aspirate (cB+cBMA) in operative treatment of fifth metatarsal stress fractures

The effect of concentrated Blood and Bone Marrow Aspirate (cB+cBMA) in operative treatment of fifth metatarsal stress fractures - cB+cBMA in MT-V stress fractures

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38972
Enrollment
50
Registered
2013-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatique fracture stress bone reaction stress fracture

Interventions

Experienced foot/ankle or trauma orthopedic surgeons will perform the surgeries. The surgery will be internal fixation and bone graft, with use of an intramedullary lag screw and an internal bone gr

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: skeletally mature stress fracture of fifth metatarsal on X-ray

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Radiological time to fracture union (in weeks)—

Secondary

MeasureTime frame
- time to clinical union (weeks) - complication rate and safety - patient function and satisfaction (FAAM, AOFAS, SF36) - analysis of the composition of the aspirate (CD 34, CD 45, CD 105, CD 146, CD 90, CD 271, CFU-F assay, absoluut aantal cellen, 7 AAD, qRT-PCR analyse) - analysis of the bone biopsions - eventually adjust the research protocol for the RCT phase (phase II)—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)