Clinical trial NCT04740749: Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System
Official title: Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System: a Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Compress Compliant Pre-Stress System
Malignant Bone Tumor
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Compress device survival
timeFrame: 25 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: 25 years
measure: Partial weight-bearing (crutches): duration
timeFrame: 25 years
measure: Radiography: signs of osseointegration
timeFrame: 25 years
measure: EORTC Core Quality of Life questionnaire (QLQ-C30)
timeFrame: 25 years
measure: Functional status
timeFrame: 25 years
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven/UZLeuven
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Friedl Sinnaeve
role: PRINCIPAL_INVESTIGATOR
References: