- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04650594
Functional Outcomes of Knee Protheses for Malignant Tumours of Bone (ISOMUTAR)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59037
- Hop Swynghedauw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Christophe Szymanski, MD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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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