Functional Outcomes of Knee Protheses for Malignant Tumours of Bone (ISOMUTAR)

November 8, 2022 updated by: University Hospital, Lille

Clinical Results, Isokinetic Analysis and Radiologic Outcomes of Knee MUTARS Protheses Replacement for Malignant Tumours of Bone

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.

Study Overview

Status

Terminated

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • 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 Locations

      • Lille, France, 59037
        • Hop Swynghedauw

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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: case group
Patients with knee bone malignancy
Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with active locking of the operated knee
Time Frame: Baseline
rate of patients with successful locking will be estimated by the frequency observed Active locking of the operated knee
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of joint amplitudes
Time Frame: Baseline
Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,
Baseline
Presence of frontal and sagittal laxity
Time Frame: Baseline
Functional results of patients with medullary reconstruction prosthesis
Baseline
Musculoskeletal Tumour Society Scoring System (MSTS)
Time Frame: Baseline
The MSTS Score may be used as a functional measure for patients with sarcoma involving the upper limb. The score includes 6 measures (pain, function, emotional acceptance, hand position, manual dexterity, lifting ability) each measure with a maximum of 5 points. The maximum overall score is 30 points. The score is designed to be used after the procedure and is therefore only collected post-operatively.
Baseline
Oxford knee score
Time Frame: Baseline

The Oxford Knee Score (OKS) is a Patient Reported Outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty.

Each of the 12 answers are assigned the previously defined number of points. They range from 1 = least difficult to 5 = most difficult. The 12 ratings are then added together to give a total score used to assess the patient.

Functional results of patients with medullary reconstruction prosthesis

Baseline
KOOS for the daily impact (subjective score)
Time Frame: Baseline
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems Functional results of patients with medullary reconstruction prosthesis
Baseline
International Knee Society (IKS) score
Time Frame: Baseline
International Knee Society score : range 0 to 200, a higher score means a better outcome Functional results of patients with medullary reconstruction prosthesis
Baseline
Radiological evaluation
Time Frame: Baseline
Radiological results of patients with medullary reconstruction prosthesis Radiological criterion : Lower limb axis,Blackburn and Peel index for patellar height, Radiological signs of loosening
Baseline
Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®.
Time Frame: Baseline
Muscle recovery of the operated limb compared to the healthy limb
Baseline
The test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®.
Time Frame: Baseline

Muscle recovery of the operated limb compared to the healthy limb

.

Baseline

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christophe Szymanski, MD, University Hospital, Lille

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)

July 1, 2021

Primary Completion (Actual)

November 21, 2021

Study Completion (Actual)

November 21, 2021

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 1, 2020

First Posted (Actual)

December 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2019_60
  • 2020-A01796-33 (Other Identifier: ID-RCB number,ANSM)

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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