Hôpital Privé Jean Mermoz
Lyon, 69008, France
NCT Number: NCT05435690
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Lyon, 69008, France
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Computer-assisted arthroplasty
Time frame: Month 12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
Time frame: Month 3
Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score
Time frame: Month 3
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 12
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Month 3
Quality of life evaluation on EuroQol 5D
Time frame: Month 12
Quality of life evaluation on EuroQol 5D
Time frame: Month 3
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time frame: Month 12
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Time frame: Day 0
Surgery duration
Time frame: Month 1
Hospitalization duration
Time frame: Month 12
Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12
Time frame: Month 1
Description of a possible correlation between preoperative laxity and postoperative outcome
Time frame: Month 12
Descriptive analysis of adverse events
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: NaviKnee
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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