To study the effect of using cB+cBMA in the operative treatment of MT-V stress fractures on the time to fracture healing.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiological time to fracture union (in weeks)
Secondary outcome
- 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)
Background summary
Fifth metatarsal (MT-V) stress fractures are ill-famed for their long time to
union. Even the current gold standard, being operative treatment, does not
present optimal results with a mean time to fracture union of grossly 18 weeks.
The aim of the current trial is to study if it is possible to shorten this time
to fracture union after operative treatment of MT-Vstress fractures with use of
concentrated blood and bone marrow aspirate (cB+cBMA).
Study objective
To study the effect of using cB+cBMA in the operative treatment of MT-V stress
fractures on the time to fracture healing.
Study design
This study will be a patient and evaluator blinded randomized, controlled
trial. A standard operative treatment (no supplementation with cB+cBMA) will be
used as control group.
Intervention
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 graft from the decortication (a
little piece is used as a biopsy for further research) along the fracture
lines.
From all patients a cB+cBMA will be obtained. This will be used for laboratory
analysis and will be added to the fracture site together with the internal bone
graft in the intervention group.
The cB+cBMA will be obtained through needle aspiration from patient*s own iliac
crest and utilizing MarrowStim Concentration System (Biomet Biologics). This
device will concentrate the aspirate by centrifuge and filtering.
Study burden and risks
We expect that the intervention risk is low.
The bone marrow will be obtained during the operation, while patients are
anesthetized; they do not feel it. The centrifugation and filtration happen
when the surgeon starts with the open reduction and internal fixation of the
MT-V fracture, so no extended OR time (only 5 minutes) is expected.
Possible known risk of collecting bone marrow from the iliac crest are
hematoma, (temporary) hyper/hypoesthesia, infection, and pain. Risk of adding
the cBMA to the fracture site is local pain.
Furthermore surgery of MT-V fractures can lead to common complications of
surgery like local hematoma, neurological failure and infection. It is also
possible to not reduce the local pain. Possibly surgery cannot prevent delayed-
or non-union of the fracture. Surgery is considered the gold standard of
treatment for these fractures at the moment.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44856.018.13 |
| OMON | NL-OMON19971 |