Skip to main content
OpenTrials
Completed

NCT Number: NCT04650594

Functional Outcomes of Knee Protheses 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Disease Bone Cancer Bone Diseases Bone Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hop Swynghedauw

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MUTARS® modular reconstruction prostheses

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Measurement of joint amplitudes

    Time frame: Baseline

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

  2. Presence of frontal and sagittal laxity

    Time frame: Baseline

    Functional results of patients with medullary reconstruction prosthesis

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

    .

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: ISOMUTAR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 2, 2020
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.