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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04740749
Acronym
Compress
Enrollment
200
Registered
2021-02-05
Start date
2021-09-01
Completion date
2023-08-24
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compress Compliant Pre-Stress System, Malignant Bone Tumor

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.

Interventions

DEVICECompress Compliant Pre-Stress System

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compress device survival25 yearsRevision 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

MeasureTime frameDescription
Postoperative complications25 yearsClinical assessment of postoperative complications. Complications will be classified acoording to Henderson classification.
Partial weight-bearing (crutches): duration25 yearsClinical assessment to determine duration of partial weight-bearing
Radiography: signs of osseointegration25 yearsRadiographic assessment
EORTC Core Quality of Life questionnaire (QLQ-C30)25 yearsTo assess the quality of life
Functional status25 yearsMusculoskeletal Tumor Society scoring system (MSTS) is used to determine the the physical and mental health

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026