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

June 27, 2024 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KU Leuven/UZLeuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
25 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 25 years
Clinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.
25 years
Partial weight-bearing (crutches): duration
Time Frame: 25 years
Clinical assessment to determine duration of partial weight-bearing
25 years
Radiography: signs of osseointegration
Time Frame: 25 years
Radiographic assessment
25 years
EORTC Core Quality of Life questionnaire (QLQ-C30)
Time Frame: 25 years
To assess the quality of life
25 years
Functional status
Time Frame: 25 years
Musculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health
25 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Friedl Sinnaeve, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S64761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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