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

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ClinicalTrials.gov Identifier: NCT04740749
Recruitment Status : Not yet recruiting
First Posted : February 5, 2021
Last Update Posted : June 15, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.


Condition or disease Intervention/treatment Phase
Compress Compliant Pre-Stress System Malignant Bone Tumor Device: Compress Compliant Pre-Stress System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System: a Prospective Study
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2046
Estimated Study Completion Date : December 2046
Arms and Interventions
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Arm Intervention/treatment
Prospective group
Patients who have to undergone the implant surgery
 Device: Compress Compliant Pre-Stress System
Treatment of malignant femor tumors with the Compress Compliant Pre-Stress System
Retrospective group
Patients that have already undergone the implant surgery
 Device: Compress Compliant Pre-Stress System
Treatment of malignant femor tumors with the Compress Compliant Pre-Stress System


Outcome Measures
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Primary Outcome Measures :
  1. Compress device survival [ Time Frame: 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 :
  1. Postoperative complications [ Time Frame: 25 years ]
    Clinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.

  2. Partial weight-bearing (crutches): duration [ Time Frame: 25 years ]
    Clinical assessment to determine duration of partial weight-bearing

  3. Radiography: signs of osseointegration [ Time Frame: 25 years ]
    Radiographic assessment

  4. EORTC Core Quality of Life questionnaire (QLQ-C30) [ Time Frame: 25 years ]
    To assess the quality of life

  5. Functional status [ Time Frame: 25 years ]
    Musculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health


Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740749


Contacts
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Contact: Friedl Sinnaeve +32 16 34 08 89 friedl.sinnaeve@uzleuven.be
Contact: Lennart Scheys +32 16 08 85 lennart.scheys@uzleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04740749    
Other Study ID Numbers: S64761
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases