Individualised compared to off-the-shelf total knee arthroplasty results in lower and less variable patellar tilt.
Wouter Beel, Elliot Sappey-Marinier, Roshan Latifi...
https://pubmed.ncbi.nlm.nih.gov/38864165Actively Recruiting
Age: 18Years +
All Genders
ID04460989
Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty
Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2024-07-01
480
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare personalized knee prostheses with conventional prostheses in patients undergoing total knee arthroplasty for gonarthrosis. The study evaluates patient satisfaction 24 months after surgery and also investigates other outcomes such as functional results, pain changes, quality of life, surgical conditions, and adverse events related to arthroplasty. Participants receive either a standard implant or a customized implant in a randomized, single-blind, two-group design. The study observes and compares these groups over time to assess the impact of the different prosthesis types on various health and surgical parameters. Throughout the 24 months following surgery, participants complete self-questionnaires including the IKS score, SF12 score, KOOS score, and Forgotten Joint Score to measure satisfaction, function, and quality of life. Researchers also monitor surgical details like operation duration, hospitalization length, blood loss, and complications to understand the safety and outcomes associated with each implant type.
CONDITIONS
Brief Title
Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult man or woman who has signed consent to participate in the study
- Patient with uni- or bilateral primary gonarthrosis
- Indication established for total knee arthroplasty
You will not qualify if you...
- History of knee arthroplasty or osteotomy
- History of knee fracture
- Inflammatory rheumatic disease or other progressive disease affecting functional prognosis
- Joint or extra-articular deformities of lower limb of traumatic origin
- Neurological diseases or stroke sequelae
- Mental disability or other difficulties understanding or following the protocol
- Not affiliated with the French social security scheme
- Under legal protection, guardianship, or trusteeship
- Currently included in another therapeutic study or participated in one within the last three months
- Arthroplasty already performed
- Per operative complications in bone, ligament, or nerve
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospitalization period following surgery
Participants undergo total knee replacement surgery with either a standard or customized implant and receive immediate post-operative care.
1 surgical visit and hospitalization
Post-operative Follow-up
Duration - Up to 24 months
Participants are followed to assess recovery, functional outcome, pain progression, quality of life, and any adverse events related to arthroplasty.
Regular follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Centre Orthopédique Santy
Lyon, France, 69008
Actively Recruiting
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Research Team
M
Michel BONNIN, MD
T
Tarik AIT SI SELMI, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty.
Elliot Sappey-Marinier, Wouter Beel, ReSurg...
https://pubmed.ncbi.nlm.nih.gov/38864156