NCT04650594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2021

Completed
Last Updated

April 21, 2026

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

November 24, 2020

Last Update Submit

April 16, 2026

Conditions

Knee DiseaseBone Cancer

Keywords

Tumourprosthese replacementfunctional outcomeskneeisokinetic

Outcome Measures

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

    Baseline

Secondary Outcomes (9)

  • Measurement of joint amplitudes

    Baseline

  • Presence of frontal and sagittal laxity

    Baseline

  • Musculoskeletal Tumour Society Scoring System (MSTS)

    Baseline

  • Oxford knee score

    Baseline

  • KOOS for the daily impact (subjective score)

    Baseline

  • +4 more secondary outcomes

Study Arms (1)

case group

EXPERIMENTAL

Patients with knee bone malignancy

Procedure: MUTARS® modular reconstruction prostheses

Interventions

MUTARS® modular reconstruction prosthesesPROCEDURE

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

case group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hop Swynghedauw

Lille, 59037, France

Location

Related Publications (1)

  • 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.

    PMID: 37119875RESULT

MeSH Terms

Conditions

Bone NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal Diseases

Study Officials

  • Christophe Szymanski, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

July 1, 2021

Primary Completion

November 21, 2021

Study Completion

November 21, 2021

Last Updated

April 21, 2026

Record last verified: 2022-05

Locations

FR(1)