Functional Outcomes of Knee Protheses for Malignant Tumours of Bone

NCT ID: NCT04650594

Last Updated: 2022-11-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2021-11-21

Brief Summary

The placement of mega knee prosthesis is a necessity after a large tumor resection and oncological. These mega knee prostheses implanted in the context of oncological surgery have been very few evaluated in the literature.

Active knee extension is essential in order to walk properly. The study propose the evaluation of this prosthesis by checking the possibility of locking of the prosthetic joint and thus the possibility of active walking.

A more in-depth, isokinetic analysis at 1 year of follow-up will also be done in an exploratory manner, as the literature has no data on this subject.

Conditions

Knee Disease; Bone Cancer

Study Design

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

Study Groups

case group

Patients with knee bone malignancy

Group Type: EXPERIMENTAL

MUTARS® modular reconstruction prostheses

Intervention Type: PROCEDURE

Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year

Interventions

MUTARS® modular reconstruction prostheses

Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year,
• Cardiological follow-up including at least one ECG and a clinical examination of less than 1 year (ability to perform the isokinetic test),
• Written informed consent from patient,
• Socially insured patient,
• Patient willing to comply with all study procedures and study duration.

Exclusion Criteria

• - Underage,
• Less than a one-year follow-up after surgery (stability of results is not achieved if follow-up is less than one year),
• Meniscal lesion knee healthy side,
• Prosthetic surgery of the knee healthy side,
• Patient with an unbound fracture,
• Patient without cardiological follow-up,
• Pregnant or breastfeeding woman,
• Inability to receive information, consent and participate in the whole study,
• No social insurance cover,
• No written consent,
• Person under judicial protection or deprived of liberty.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe Szymanski, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hop Swynghedauw

Lille, , France

Countries

France

Other Identifiers

2020-A01796-33

Identifier Type: OTHER

Identifier Source: secondary_id

2019_60

Identifier Type: -

Identifier Source: org_study_id