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

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

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

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee; Total Knee Arthroplasty; Total Knee Replacement; Knee Disease
• Intervention / Treatment: Device: patient with knee arthroplasty

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Vanessa GRIMAUD; Phone Number: 0667267075; Email: vanessa.grimaud@coringroup.com

Study Locations

• France
  • Lyon, France, 69000
    • Recruiting
    • Hôpital de la Croix-Rousse, Hospices Civils de Lyon
    • Contact: Elvire SERVIEN, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices	Implants survival	10-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of clinical performance	Change of clinical performance using the International Knee Society (IKS) score	baseline (pre-surgery) to 10-year
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
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
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

Collaborators and Investigators

• Sponsor: Corin
• Investigators: Principal Investigator: Elvire SERVIEN, MD,PhD, Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2011
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Arthroplasty; Prosthesis; Knee Arthroplasty; Implants; HLS implants; postero-stabilized prosthesis; third condyle
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 0904-T-KNEE-RM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No