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CompletedNCT04650594ISOMUTARUpdated Apr 21, 2026

Functional Outcomes of Knee Protheses for Malignant Tumours of Bone

An interventional study of MUTARS® modular reconstruction prostheses in Knee Disease and Bone Cancer, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Disease
  • Bone Cancer

Keywords

  • Tumour
  • prosthese replacement
  • functional outcomes
  • knee
  • isokinetic
03

In context

Bone Neoplasms

322 studies on the registry are indexed under Bone Neoplasms; 81 are open to participants now.

This study's enrollment of 9 is below the median of 50 across 218 interventional studies indexed under Bone Neoplasms.

Browse Bone Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    case group

    Patients with knee bone malignancy

    Procedure: MUTARS® modular reconstruction prostheses

Interventions

  • ProcedureMUTARS® modular reconstruction prostheses

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline

Secondary outcomes

  1. Measurement of joint amplitudes

    Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,

    Time frame: Baseline

  2. Presence of frontal and sagittal laxity

    Functional results of patients with medullary reconstruction prosthesis

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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

    Time frame: Baseline

  6. 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

    Time frame: Baseline

  7. 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

    Time frame: Baseline

  8. 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

    Time frame: Baseline

  9. 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 .

    Time frame: Baseline

07

Study locations

1 site
  • Hop Swynghedauw
    Lille, 59037, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04650594
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Dec 2, 2020
Start date
Jul 1, 2021
Primary completion
Nov 21, 2021
Completion
Nov 21, 2021
Last update
Apr 21, 2026

Study contacts

Christophe Szymanski, MD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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