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Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System

NCT04740749 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

  • Compress Compliant Pre-Stress System
  • Malignant Bone Tumor

Interventions

DEVICE

Compress Compliant Pre-Stress System

Treatment of malignant femor tumors with the Compress Compliant Pre-Stress System

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Friedl Sinnaeve · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2023-08-24
Completion
2023-08-24

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04740749 on ClinicalTrials.gov