Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727060
• Other study ID #: 0904-T-KNEE-RM
• Status: Recruiting
• Start date: December 15, 2011
• Est. completion date: June 2031

Study information

• Verified date: August 2023
• Source: Corin
• Contact: Vanessa GRIMAUD
• Phone: 0667267075
• Email: vanessa.grimaud[@]coringroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

Description:

It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely. All patients treated with HLS KneeTec (cemented, non-cemented 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. Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis. Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2031
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:

1. Adult patients older than 18 years old.

2. Patients who have undergone routine preoperative clinical evaluations prior to their Total Knee Replacement surgery and implanted with one of the following prostheses from the HLS range: HLS-1, HLS-2, HLS Evolution and HLS Noetos between their first date of use in 1987 and their last date of use as normal practice at the participating site in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.

3. Patients who have been informed about their participation into an observational study.

For the HLS KneeTec prospective group (with retrospective surgeries):

1. Adult patients older than 18 years old.

2. Patients who have undergone routine preoperative clinical evaluations and received a TKR or are suitable candidates for a TKR with a fixed or mobile postero-stabilized HLS KneeTec prosthesis (cementless, cemented or hybrid combination) for the treatment of a primary or secondary knee osteoarthritis and inflammatory disease such as rheumatoid arthritis in accordance to indications and intended use as described in the Instruction for Use (IFU) of the study devices.

3. Patients who are willing and able to complete the scheduled FU visits.

4. Patients who have been informed about their participation into an observational registry study

Exclusion Criteria:

• Patients mentally incompetent or unable to understand what participation in the study entails.
• Patients who present signs and symptoms of any of the known contraindications described in the Instruction for Use (IFU) of the study devices.
• Patients who deny their participation into the study.

Related Conditions & MeSH terms

• Knee Disease
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

Device:
• patient with knee arthroplasty

Locations

Country	Name	City	State
France	Hopital de la Croix-Rousse, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Corin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices	Implants survival	10-year
Secondary	Evaluation of clinical performance	Change of clinical performance using the International Knee Society (IKS) score	baseline (pre-surgery) to 10-year
Secondary	Evaluation of patient satisfaction with the surgery	Patients satisfaction post-surgery and any change during time up to 10-year FU using satisfaction questionnaire	time up to 10-year FU
Secondary	Radiographic evaluation	Implant positioning and stability, presence/absence of progressive radiolucent lines around implant components, any sign of loosening components via radiological evaluation from baseline (1-year FU) to 10-year FU.	baseline (1-year FU) to 10-year FU
Secondary	Evaluation of safety of the study implants	Number, severity and causal relationship of procedure or implant-related Adverse Events (AEs) starting intraoperatively up to 10-year FU.	time up to 10-year FU