Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04740749 |
| Other study ID # |
S64761 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2021 |
| Est. completion date |
December 2046 |
Study information
| Verified date |
June 2021 |
| Source |
Universitaire Ziekenhuizen Leuven |
| Contact |
Friedl Sinnaeve |
| Phone |
+32 16 34 08 89 |
| Email |
friedl.sinnaeve[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In the treatment of malignant bone tumors, it may be necessary to remove large areas of the
femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative
technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS;
Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar,
to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the
loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem.
Young patients cured of tumors have a long life expectancy and a compelling need for
prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant
longevity.
Although the initial results are encouraging, there is a need for additional mid- to
long-term survival data from larger patient series showing longevity of the system, as well
as reporting of functional outcome. Furthermore, to the best of our knowledge, no study
examining the survival of the device using prospective data already exists. In addition, no
studies were found examining the quality of life of the patients with the CPS system.
Description:
In the treatment of malignant bone tumors, it may be necessary to remove large areas of the
femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative
technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS;
Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar,
to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the
loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem.
Young patients cured of tumors have a long life expectancy and a compelling need for
prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant
longevity. Since 1999, the CPS has been routinely placed on the orthopedics - UZ Leuven
service and, as a result, more than 100 patients have been treated in this way. However,
there are only few studies reporting on long-term performance of this system. In addition,
limited data reporting functional outcome were found.
Although the initial results are encouraging, there is a need for additional mid- to
long-term survival data from larger patient series showing longevity of the system, as well
as reporting of functional outcome. Furthermore, to the best of our knowledge, no study
examining the survival of the device using prospective data already exists. In addition, no
studies were found examining the quality of life of the patients with the CPS system.
