Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System
- Conditions
- Malignant Bone TumorCompress Compliant Pre-Stress System
- Interventions
- Device: Compress Compliant Pre-Stress System
- Registration Number
- NCT04740749
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
- Patients are/will be operated from 26/08/1999 onwards in UZ Leuven
- Implantation of the Compress Compliant Pre-Stress Device
- Informed consent obtained
- Patients are able to complete the questionnaires
- Age: minimum 7 years old
- N/A
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prospective group Compress Compliant Pre-Stress System Patients who have to undergone the implant surgery Retrospective group Compress Compliant Pre-Stress System Patients that have already undergone the implant surgery
- Primary Outcome Measures
Name Time Method Compress device survival 25 years Revision will be used to determine implant survival. Revision will be defined as the explantation of any fixation mechanism: anchor plug, traction bar, spindle, sleeve, fixation pin
- Secondary Outcome Measures
Name Time Method Partial weight-bearing (crutches): duration 25 years Clinical assessment to determine duration of partial weight-bearing
Functional status 25 years Musculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health
Postoperative complications 25 years Clinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.
Radiography: signs of osseointegration 25 years Radiographic assessment
EORTC Core Quality of Life questionnaire (QLQ-C30) 25 years To assess the quality of life
Trial Locations
- Locations (1)
KU Leuven/UZLeuven
🇧🇪Leuven, Vlaams-Brabant, Belgium