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

NCT04740749 | Terminated

• 1 other identifier: S64761
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Compress Compliant Pre-Stress System; Malignant Bone Tumor

Outcome Measures

Primary Outcomes (1)

• Compress device survival

  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

  25 years

Secondary Outcomes (5)

• Postoperative complications

  25 years

• Partial weight-bearing (crutches): duration

  25 years

• Radiography: signs of osseointegration

  25 years

• EORTC Core Quality of Life questionnaire (QLQ-C30)

  25 years

• Functional status

  25 years

Study Arms (2)

Prospective group

OTHER

Patients who have to undergone the implant surgery

Device: Compress Compliant Pre-Stress System

Retrospective group

OTHER

Patients that have already undergone the implant surgery

Device: Compress Compliant Pre-Stress System

Interventions

Compress Compliant Pre-Stress System DEVICE

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

Prospective group; Retrospective group

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

KU Leuven/UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Friedl Sinnaeve

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 5, 2021
• Study Start: September 1, 2021
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: July 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)