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
About this trial
This is an interventional other trial for Compress Compliant Pre-Stress System
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
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
NCT ID
NCT04740749
First Posted
February 1, 2021
Last Updated
June 14, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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
Learn more about this trial
Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System
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