Functional Outcomes of Knee Protheses for Malignant Tumours of Bone
- Conditions
- Bone CancerKnee Disease
- Interventions
- Procedure: MUTARS® modular reconstruction prostheses
- Registration Number
- NCT04650594
- Lead Sponsor
- University Hospital, Lille
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
- 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.
-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description case group MUTARS® modular reconstruction prostheses Patients with knee bone malignancy
- Primary Outcome Measures
Name Time Method Rate of patients with active locking of the operated knee Baseline rate of patients with successful locking will be estimated by the frequency observed Active locking of the operated knee
- Secondary Outcome Measures
Name Time Method Presence of frontal and sagittal laxity Baseline Functional results of patients with medullary reconstruction prosthesis
Musculoskeletal Tumour Society Scoring System (MSTS) 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.
KOOS for the daily impact (subjective score) 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
International Knee Society (IKS) score Baseline International Knee Society score : range 0 to 200, a higher score means a better outcome Functional results of patients with medullary reconstruction prosthesis
Oxford knee score 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 prosthesisThe test angular velocities are 60°/s and 180°/s in concentric contraction mode by isokinetic machine type Contrex®. Baseline Muscle recovery of the operated limb compared to the healthy limb
.Measurement of joint amplitudes Baseline Functional results of patients with medullary reconstruction prosthesis,joint amplitudes in flexion-extension and in active, passive,
Radiological evaluation 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
Isokinetic strength of the quadriceps and ischio-leg muscles during knee flexion and extension by isokinetic machine type Contrex®. Baseline Muscle recovery of the operated limb compared to the healthy limb
Trial Locations
- Locations (1)
Hop Swynghedauw
🇫🇷Lille, France