Clinical trial NCT04650594: Functional Outcomes of Knee Protheses for Malignant Tumours of Bone
Official title: Clinical Results, Isokinetic Analysis and Radiologic Outcomes of Knee MUTARS Protheses Replacement for Malignant Tumours of Bone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Knee Disease
Bone Cancer
Keywords: Tumour
prosthese replacement
functional outcomes
knee
isokinetic
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of patients with active locking of the operated knee
timeFrame: Baseline
Secondary outcomes:
measure: Measurement of joint amplitudes
timeFrame: Baseline
measure: Presence of frontal and sagittal laxity
timeFrame: Baseline
measure: Musculoskeletal Tumour Society Scoring System (MSTS)
timeFrame: Baseline
measure: Oxford knee score
timeFrame: Baseline
measure: KOOS for the daily impact (subjective score)
timeFrame: Baseline
measure: International Knee Society (IKS) score
timeFrame: Baseline
measure: Radiological evaluation
timeFrame: Baseline
measure: Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®.
timeFrame: Baseline
measure: The test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®.
timeFrame: Baseline
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Swynghedauw
Study officials:
affiliation: University Hospital, Lille
name: Christophe Szymanski, MD
role: PRINCIPAL_INVESTIGATOR
References: