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

Primary Purpose

Knee Disease, Bone Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MUTARS® modular reconstruction prostheses
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Disease focused on measuring Tumour, prosthese replacement, functional outcomes, knee, isokinetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hop Swynghedauw

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

case group

Arm Description

Patients with knee bone malignancy

Outcomes

Primary Outcome Measures

Rate of patients with active locking of the operated knee
rate of patients with successful locking will be estimated by the frequency observed Active locking of the operated knee

Secondary Outcome Measures

Measurement of joint amplitudes
Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,
Presence of frontal and sagittal laxity
Functional results of patients with medullary reconstruction prosthesis
Musculoskeletal Tumour Society Scoring System (MSTS)
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.
Oxford knee score
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
KOOS for the daily impact (subjective score)
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
International Knee Society (IKS) score
International Knee Society score : range 0 to 200, a higher score means a better outcome Functional results of patients with medullary reconstruction prosthesis
Radiological evaluation
Radiological results of patients with medullary reconstruction prosthesis Radiological criterion : Lower limb axis,Blackburn and Peel index for patellar height, Radiological signs of loosening
Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®.
Muscle recovery of the operated limb compared to the healthy limb
The test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®.
Muscle recovery of the operated limb compared to the healthy limb .

Full Information

First Posted
November 24, 2020
Last Updated
November 8, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT04650594
Brief Title
Functional Outcomes of Knee Protheses for Malignant Tumours of Bone
Acronym
ISOMUTAR
Official Title
Clinical Results, Isokinetic Analysis and Radiologic Outcomes of Knee MUTARS Protheses Replacement for Malignant Tumours of Bone
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
investigator's decision
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
November 21, 2021 (Actual)
Study Completion Date
November 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Disease, Bone Cancer
Keywords
Tumour, prosthese replacement, functional outcomes, knee, isokinetic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
case group
Arm Type
Experimental
Arm Description
Patients with knee bone malignancy
Intervention Type
Procedure
Intervention Name(s)
MUTARS® modular reconstruction prostheses
Intervention Description
Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year
Primary Outcome Measure Information:
Title
Rate of patients with active locking of the operated knee
Description
rate of patients with successful locking will be estimated by the frequency observed Active locking of the operated knee
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Measurement of joint amplitudes
Description
Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,
Time Frame
Baseline
Title
Presence of frontal and sagittal laxity
Description
Functional results of patients with medullary reconstruction prosthesis
Time Frame
Baseline
Title
Musculoskeletal Tumour Society Scoring System (MSTS)
Description
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.
Time Frame
Baseline
Title
Oxford knee score
Description
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
Time Frame
Baseline
Title
KOOS for the daily impact (subjective score)
Description
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
Time Frame
Baseline
Title
International Knee Society (IKS) score
Description
International Knee Society score : range 0 to 200, a higher score means a better outcome Functional results of patients with medullary reconstruction prosthesis
Time Frame
Baseline
Title
Radiological evaluation
Description
Radiological results of patients with medullary reconstruction prosthesis Radiological criterion : Lower limb axis,Blackburn and Peel index for patellar height, Radiological signs of loosening
Time Frame
Baseline
Title
Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®.
Description
Muscle recovery of the operated limb compared to the healthy limb
Time Frame
Baseline
Title
The test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®.
Description
Muscle recovery of the operated limb compared to the healthy limb .
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Szymanski, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Swynghedauw
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Functional Outcomes of Knee Protheses for Malignant Tumours of Bone

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