In patients with benign bone tumors, the defect originated from curretage of the tumor, will be filled with Progentix TCP. The bone regenerative capacity of Progentix TCP will be compared to the capacity of autologous bone (the golden standard).…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Skeletal neoplasms benign
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
After 6 weeks, 3 months, 6 months, 1 year and 2 years, the amount of bone
formed by "creeping substitution" in the bone defect will be assessed by means
of X-rays.
Secondary outcome
not applicable
Background summary
The human body is not capable of repairing bone defects above a certain size by
itself. This is only possible when the defect is filled with a temporary
substance. Currently, autologous bone is the golden standard for filling
defects originated from curretage of benign bone tumors. Often patients have
longlasting pain at the donorsite (the site where autologous bone was taken).
Progentix BV has recently developen a novel b-tricalciumfosfate, which has the
property to actively induce bone formation by attracting patient-own stemcells
and stimulating the osteogenic differentiation of these cells.
Our hypothesis is, that Progentix TCP is at least as good a bone substitute as
autologous bone, while at the same time, the occurance of pain at the donorsite
is diminished.
Study objective
In patients with benign bone tumors, the defect originated from curretage of
the tumor, will be filled with Progentix TCP. The bone regenerative capacity of
Progentix TCP will be compared to the capacity of autologous bone (the golden
standard). When Progentix TCP indeed has the same qualities as autologous bone,
the harvesting of autologous bone and the accompanying complications can be
prevented in the future.
Study design
In a pilot study ten patients will be treated with Progentix TCP after
curretage of a benign bone tumor. After 6 weeks, 3 months, 6 months, 1 year and
2 years X-rays will be made to determine whether the bone defect is filled with
patient-own bone by means of "creeping substitution".
Intervention
Following curettage of the benign bone tumor the defect will be filled with
Progentix TCP. So, a surgical intervention will take place.
Study burden and risks
Possible delayed closing of the bone defect via creeping substitution with
living patient-own bone.
postbus 50000
7500 KA Enschede
NL
postbus 50000
7500 KA Enschede
NL
Listed location countries
Age
Inclusion criteria
benign bonetumors to be treated with curettage
Exclusion criteria
Use of Progentix TCP synthetic cancellous bone void filler is CONTRAINDICATED in the presence of one or more of the following clinical situations: Malignant bonetumors, In case of severe metabolic or systemic bone disorders that affect bone or wound healing, In case of acute and chronic infections in the operated area (soft tissue infections; inflamed, bacterial bone diseases; osteomyelitis), In case of treatment with pharmaceuticals interfering with the calcium metabolism.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL15256.044.08 |