Knee DiseaseISOMUTARNCT04650594
Functional Outcomes of Knee Protheses for Malignant Tumours of Bone
A study testing MUTARS® modular reconstruction prostheses in people with Knee Disease and Bone Cancer, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Disease, Bone Cancer
- What is being tested?
- MUTARS® modular reconstruction prostheses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 21 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Knee Disease, Bone Cancer
- Being tested
- MUTARS® modular reconstruction prostheses
- Keywords
- Tumour, prosthese replacement, functional outcomes, knee, isokinetic
- Medical subject headings
- Bone Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUTARS® modular reconstruction prosthesesProcedure or surgery
Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | Patients with knee bone malignancy Receives: Procedure: MUTARS® modular reconstruction prostheses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (9)
Measurement of joint amplitudes
Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,
Measured: Baseline
Presence of frontal and sagittal laxity
Functional results of patients with medullary reconstruction prosthesis
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jul 2021
- Primary completion21 Nov 2021
- Study completion21 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Szymanski, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650594
- Sponsor's protocol ID
- 2019_60
- Other IDs
- 2020-A01796-33
- Acronym
- ISOMUTAR
- Status last verified
- May 2022
- First submitted
- 24 Nov 2020
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rodrigues V, Szymanski C, Saab M, Maynou C, Tiffreau V, Wieczorek V, Dartus J, Amouyel T. Recovery of leg strength based on isokinetic testing after tumor resection and reconstruction with a modular rotating hinge knee system: Prospective cross-sectional study with a minimum follow-up of 24 months. Orthop Traumatol Surg Res. 2023 Nov;109(7):103631. doi: 10.1016/j.otsr.2023.103631. Epub 2023 Apr 28.
PubMed 37119875
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results, Isokinetic Analysis and Radiologic Outcomes of Knee MUTARS Protheses Replacement for Malignant Tumours of Bone
- ClinicalTrials.gov ID
- NCT04650594
- Acronym / sponsor ID
- ISOMUTAR / 2019_60
- Conditions
- Knee Disease, Bone Cancer
- Keywords
- Tumour, prosthese replacement, functional outcomes, knee, isokinetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 21 Nov 2021 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Procedure: MUTARS® modular reconstruction prosthesesPatients with knee bone malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- - 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MUTARS® modular reconstruction prosthesesPatients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year | Procedure or surgery | case group |
Primary outcome
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
9 secondary outcomes
Measurement of joint amplitudes
Time frame: Baseline
Presence of frontal and sagittal laxity
Time frame: Baseline
Musculoskeletal Tumour Society Scoring System (MSTS)
Time frame: Baseline
Oxford knee score
Time frame: Baseline
KOOS for the daily impact (subjective score)
Time frame: Baseline
International Knee Society (IKS) score
Time frame: Baseline
Radiological evaluation
Time frame: Baseline
Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®.
Time frame: Baseline
The test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®.
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 37119875Rodrigues V, Szymanski C, Saab M, Maynou C, Tiffreau V, Wieczorek V, Dartus J, Amouyel T. Recovery of leg strength based on isokinetic testing after tumor resection and reconstruction with a modular rotating hinge knee system: Prospective cross-sectional study with a minimum follow-up of 24 months. Orthop Traumatol Surg Res. 2023 Nov;109(7):103631. doi: 10.1016/j.otsr.2023.103631. Epub 2023 Apr 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Szymanski, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MUTARS® modular reconstruction prostheses in people with Knee Disease and Bone Cancer, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with active locking of the operated knee (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.