Clinical trial · Interventional
Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System
Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System: a Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Masterthesis completed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Compress Compliant Pre-Stress System | — | UNRESOLVED | — |
| Malignant Bone Tumor | Malignant Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Compress Compliant Pre-Stress System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Prospective group
- description
- Patients who have to undergone the implant surgery
- interventionNames
- Device: Compress Compliant Pre-Stress System
- type
- OTHER
- label
- Retrospective group
- description
- Patients that have already undergone the implant surgery
- interventionNames
- Device: Compress Compliant Pre-Stress System
Primary outcomes (1)
- measure
- Compress device survival
- timeFrame
- 25 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available