Evaluation of the Compress Distal Femoral Replacement System

NCT ID: NCT00591812

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-04-30
• Study Completion Date: 2009-05-31

Brief Summary

Patients in this study require a replacement of a lower thighbone and knee joint. A new device, called the ComPreSs, will be used in this study to replace the lower thighbone. This new device has not yet been approved by the Food and Drug Administration (FDA). There is not enough data to assure that it is as good as other devices currently available. Taking part in this study will help provide data to the FDA. Other devices used to replace large pieces of bone and joints in the leg can result in damage to the bone over time. The bone damage can cause the device to come loose from the bone. This is a bad problem, and causes pain, and often more surgery is needed. This new device connects to the bone in a different way to prevent some of the problems seen with other devices. The new device protects the bone, and may help the replacement last longer. So far, the device has been used in over 50 patients on a selective basis.

Conditions

Lower Thighbone and Knee Joint Replacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1 - ComPreSs system

Group Type: EXPERIMENTAL

ComPreSs Distal Femoral Replacement System.

Intervention Type: DEVICE

ComPreSs system of intramedullary fixation along with the Finn Knee system

Interventions

ComPreSs Distal Femoral Replacement System.

ComPreSs system of intramedullary fixation along with the Finn Knee system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with bone tumors of the distal femur requiring primary bone resection of up to 30 cm with the resection at or below the lesser trochanter.
• Patients with prior orthopaedic oncologic conditions requiring revisions of distal femoral replacement devices with a total replacement height of 30 cm or less and the resection level is at or below the lesser trochanter.
• Patients who have a cortical bone thickness of 2.5 mm or larger in the region where the ComPreSs device would be implanted.
• Patients diagnosed with a bone tumor classified as Stage 1A, IB, IIA, IIB, or III by Enneking's classification system. (See section 12.0, #7)

Exclusion Criteria

• Patients with active infection.
• Patients who are unable to return for follow-up examinations.
• Patients who have cortical bone thickness less than 2.5 mm in the region where the ComPreSs device would be implanted.
• Patients who are unwilling or incapable of following postoperative care instructions.
• Patients requiring bilateral knee implants.
• Patients with evidence of vascular insufficiency (arterial and/or venous).
• Patients having Parkinson's disease, severe muscular atrophy, neuromuscular disease in the affected limb.
• Patients with prior irradiated bone.
• Patients with metastatic cancer including carcinoma, melanoma, myeloma, lymphoma, leukemia.
• Patients with pathologic soft tissue or skeletal conditions that would prevent secure fixation of the device in the bone.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Healey, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

https://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

00-038

Identifier Type: -

Identifier Source: org_study_id