A Post-market Observational ORIGIN® CR Clinical Study

Status Not yet recruiting

Clinical Trial Summary

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure. The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.

Clinical Trial Description

The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments. Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months. ;

Study Design

Related Conditions & MeSH terms

Total Knee Replacement

Clinical Trial Details

NCT number	NCT05607966
Study type	Observational
Source	Symbios Orthopedie SA
Contact
Status	Not yet recruiting
Phase
Start date	November 2022
Completion date	June 2027

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04040985` - Legion Primary Safety and Efficacy	N/A
Recruiting	`NCT05279092` - Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study	Phase 2
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Not yet recruiting	`NCT04594447` - Physica System KR vs Physica System CR (K-20)	N/A
Completed	`NCT02413996` - Effects of Virtual Reality Rehabilitation in Patients With Total Knee Arthroplasty	N/A
Completed	`NCT01500252` - Patellar Resurfacing Versus Patellar Retention in Total Knee Arthroplasty - A Randomized Clinical Trial	Phase 4
Recruiting	`NCT04081493` - The Efficacy of Low-load Blood Flow Restricted Resistance Before TKR	N/A
Active, not recruiting	`NCT03339557` - Comparison of Three Knee Replacements	N/A
Enrolling by invitation	`NCT04513145` - Adductor Canal Block	Phase 2/Phase 3
Completed	`NCT06045078` - Aromatherapy in Total Knee Replacement	N/A
Completed	`NCT02468934` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System	N/A
Completed	`NCT02914210` - Virtual vs. Traditional Physical Therapy Following Total Knee Replacement	N/A
Withdrawn	`NCT01523418` - Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)	N/A
Completed	`NCT00795223` - Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA	Phase 4
Completed	`NCT01307202` - Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment	N/A
Completed	`NCT01515449` - Predictors of Poor Outcomes in 1038 Sigma Knees	N/A
Completed	`NCT01522781` - 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis	N/A
Completed	`NCT04166539` - Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty
Completed	`NCT03454256` - Virtual Reality Rehabilitation in Patients With Total Knee Replacement	N/A
Enrolling by invitation	`NCT06118073` - Effect of Mindfulness on Pain After Total Knee Arthroplasty	N/A