An interventional study of Kinematic aligned total knee replacement in Arthritis, Arthritis (Knee) and Osteoarthritis, sponsored by Université de Sherbrooke. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Treatment
Knee replacement surgery is a surgery designed to treat severe arthritis of the knee. However, as many as 20% of patients are not satisfied with the results of their surgery. To place the knee replacement in correct position, the kinematic alignment method, which tries to reproduce the patient normal anatomy, has shown promise in improving the satisfaction after knee replacement surgery. It is not known if using a robotic arm to assist in surgery is better than the traditional method when trying to recreate kinematic alignment.
The goal of this study is to learn if robotic assisted surgery is better than traditional method for knee replacement done using kinematic alignment. The main questions the study tries to answer are:
Participants will:
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo kinematic aligned knee replacement done using traditional instruments and cut guides
Procedure: Kinematic aligned total knee replacement
Patients will undergo kinematic aligned knee replacement done using robotic assistance
Procedure: Kinematic aligned total knee replacement
Replacement of worn knee cartilage using a prosthesis. The alignment is determined according to the patient's anatomy and ligament balance.
Radiographic alignment of the knee
Long leg anteroposterior views of both legs and lateral knee radiographs will be used to measure knee alignment and position of the knee replacement hardware. The angles measured and analyzed will be: * The hip-knee-ankle (HKA) angle * Medial proximal tibia mechanical angle (MPTAm) * Lateral distal femur mechanical angle (LDTAm) * Distal femur flexion angle (DFFA) * Posterior tibial slope (PTS) Radiographic measurements will be made by a trained observer and a fellowship-train arthroplasty surgeon.
Time frame: Pre-operative alignement and 6 months post-operative alignement.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient questionnaire (42 questions) evaluating knee pain, symptoms, function, recreational activities and knee-related quality of life. The questionnaire is score over 100 points, with a higher score meaning better knee function.
Time frame: Pre-operative, 6 weeks, 6 months, 12 months, 24 months post-operative
Forgotten joint score
A 12-questions form asking patients if they forget about their joint during activities of daily living.
Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-op
Joint perception question
A single item question asking participants how they perceive their operated knee, from "like a native or natural joint" to "like a nonfunctional joint".
Time frame: Pre-operative, 6 weeks, 6 months, 12 months and 24 months post-operative
Pain visual analog scale
Pain rated on a 10 cm visual analog scale from "no pain" to "worst pain imaginable"
Time frame: Pre-op, 6 weeks, 6, 12, 24 months
Subjective Assessment Numeric Evaluation Scale (SANE)
Single question evaluation scale asking the patient to rate their knee function from 0 (no function) to 100 (completely normal function)
Time frame: Pre-op, 6 weeks, 6, 12, 24 months
Knee range of motion
Maximum passive flexion and extension measured with goniometer
Time frame: Pre, 6 weeks, 6 and 12 months post-op
Knee stability
Anterior drawer, posterior drawer, valgus stress, varus stress. Instability rated for each test 1 to 3 by treating surgeon.
Time frame: Pre-op, 6 weeks, 6 and 12 months post-op
Intra-operative procedures
During surgery, the knee for additional intra-operative procedures to obtain a stable knee replacement will be noted: * Need for ligamentous release - lateral release, medial release, lateral retinaculum release, posterior cruciate ligament release * Need for tibial or femoral recut
Time frame: At the time of surgery
Surgical cost
Total cost of implants and equipment used will be calculated at the end of each surgical case.
Time frame: At the time of surgery
Surgical time
The time from first incision to skin closure will be noted at each surgery.
Time frame: At the time of surgery
Intra-operative complications
The incidence of intra-operative complications will be noted: * Unplanned ligament injury * Neurovascular damage * Intra-operative tibial of femoral fracture * Any other complications noted during surgery
Time frame: At the time of surgery
No study locations are listed for this record.
Plan to share: No — Anonymous individual patient data will be shared only with a direct request to the study principal investigator.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Université de Sherbrooke