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

Primary Purpose

Compress Compliant Pre-Stress System, Malignant Bone Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compress Compliant Pre-Stress System
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Compress Compliant Pre-Stress System

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Prospective group

    Retrospective group

    Arm Description

    Patients who have to undergone the implant surgery

    Patients that have already undergone the implant surgery

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Postoperative complications
    Clinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.
    Partial weight-bearing (crutches): duration
    Clinical assessment to determine duration of partial weight-bearing
    Radiography: signs of osseointegration
    Radiographic assessment
    EORTC Core Quality of Life questionnaire (QLQ-C30)
    To assess the quality of life
    Functional status
    Musculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health

    Full Information

    First Posted
    February 1, 2021
    Last Updated
    June 14, 2021
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04740749
    Brief Title
    Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System
    Acronym
    CPS
    Official Title
    Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System: a Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    December 2046 (Anticipated)
    Study Completion Date
    December 2046 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Compress Compliant Pre-Stress System, Malignant Bone Tumor

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prospective group
    Arm Type
    Other
    Arm Description
    Patients who have to undergone the implant surgery
    Arm Title
    Retrospective group
    Arm Type
    Other
    Arm Description
    Patients that have already undergone the implant surgery
    Intervention Type
    Device
    Intervention Name(s)
    Compress Compliant Pre-Stress System
    Intervention Description
    Treatment of malignant femor tumors with the Compress Compliant Pre-Stress System
    Primary Outcome Measure Information:
    Title
    Compress device survival
    Description
    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
    Time Frame
    25 years
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Clinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.
    Time Frame
    25 years
    Title
    Partial weight-bearing (crutches): duration
    Description
    Clinical assessment to determine duration of partial weight-bearing
    Time Frame
    25 years
    Title
    Radiography: signs of osseointegration
    Description
    Radiographic assessment
    Time Frame
    25 years
    Title
    EORTC Core Quality of Life questionnaire (QLQ-C30)
    Description
    To assess the quality of life
    Time Frame
    25 years
    Title
    Functional status
    Description
    Musculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health
    Time Frame
    25 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Friedl Sinnaeve
    Phone
    +32 16 34 08 89
    Email
    friedl.sinnaeve@uzleuven.be
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lennart Scheys
    Phone
    +32 16 08 85
    Email
    lennart.scheys@uzleuven.be

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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