Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
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| ClinicalTrials.gov Identifier: NCT04872855 |
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Recruitment Status :
Recruiting
First Posted : May 5, 2021
Last Update Posted : May 19, 2021
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| Condition or disease | Intervention/treatment |
|---|---|
| Total Knee Arthroplasty Knee Disease Total Knee Replacement Osteo Arthritis Knee | Device: patient with knee arthroplasty |
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in French sites where Total Knee Arthroplasty with HLS Kneetec cementless and hybrid fixation knee prosthesis is performed routinely
All patients treated with HLS KneeTec (cementless or hybrid versions) implant will be included. All eligible patients seen in consultation and who agree to participate in the study should be included, systematically and consecutively, since the initiation of the study.
Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up (FU) visits as following: 4 months (+/- 2 months); 1 year (+/- 2 months); 5 years (+/- 12 months) and 10 years (+/- 12 months).
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty |
| Actual Study Start Date : | July 17, 2020 |
| Estimated Primary Completion Date : | July 15, 2031 |
| Estimated Study Completion Date : | January 15, 2032 |
- Device: patient with knee arthroplasty
patient with HLS KneeTec cementless and hybrid fixation prosthesis
- Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec cementless and hybrid fixations up to 10 years after the surgery [ Time Frame: 10-year ]Kaplan Meier survival rate up to 10 years after the surgery.
- Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery [ Time Frame: starting preoperatively up to 10 years ]IKS score
- Evaluation of clinical performance of the HLS KneeTec cementless and hybrid fixations after the surgery [ Time Frame: 5 and 10 years ]Oxford Knee Score
- Radiographic analysis of the HLS KneeTec cementless and hybrid fixations at 4 months, 1, 5 and 10 years minimum [ Time Frame: 4 months, 1, 5 and 10 years ]radiological analysis from immediate postoperative up to 10-year FU
- Evaluation of safety performance during the surgery up to 10 years after the surgery [ Time Frame: starting intraoperatively up to 10-year FU ]Number, severity and casual relationship of procedure or implant-related adverse events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Male or female aged 18 - 80 years old at the time of the surgery
- Implanted (or with an indication) with an HLS KneeTec Cementless or hybrid fixation according to the Instructions for Use (IFU)
- Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.
Exclusion Criteria:
- Patients under guardianship and/or those who, according to the investigator or his delegated research team, will not be able to comply with the study procedures. (e.g. illiteracy, recent psychotic or manic disorders and/or inability to comply with routine follow-up visits.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872855
| Contact: Vanessa GRIMAUD | 0667267075 | vanessa.grimaud@coringroup.com |
| France | |
| Chu Angers | Not yet recruiting |
| Angers, France, 49933 | |
| Contact: Florian DUCELLIER, MD flducellier@chu-angers.fr | |
| Principal Investigator: Florian DUCELLIER, MD | |
| Clinique Du Parc | Recruiting |
| Caen, France, 14000 | |
| Contact: Bertrand GALAUD, MD +33231828282 bertrandgalaud@gmail.com | |
| Principal Investigator: Bertrand GALAUD, MD | |
| Centre Hospitalier Compiegne Noyon | Recruiting |
| Compiègne, France, 60200 | |
| Contact: Franck MABESOONE, MD F.MABESOONE@ch-compiegnenoyon.fr | |
| Sub-Investigator: Max-Olivier ROUX, MD | |
| Sub-Investigator: Cécile LATERZA, MD | |
| Principal Investigator: Franck MABESOONE, MD | |
| Principal Investigator: | Franck MABESOONE, MD | CH COMPIEGNE |
| Responsible Party: | Corin |
| ClinicalTrials.gov Identifier: | NCT04872855 |
| Other Study ID Numbers: |
CSP2017-10 |
| First Posted: | May 5, 2021 Key Record Dates |
| Last Update Posted: | May 19, 2021 |
| Last Verified: | April 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Knee Arthroplasty Prosthesis Implants HLS implants arthroplasty |
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |