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

U

University Hospital, Lille

Status

Terminated

Conditions

Knee Disease
Bone Cancer

Treatments

Procedure: MUTARS® modular reconstruction prostheses

Study type

Interventional

Funder types

Other

Identifiers

NCT04650594
2020-A01796-33 (Other Identifier)
2019_60

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

case group
Experimental group
Description:
Patients with knee bone malignancy
Treatment:
Procedure: MUTARS® modular reconstruction prostheses

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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