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

NCT04727060 | Terminated

• 1 other identifier: 0904-T-KNEE-RM
• Study Type: observational
• Target: 2,146
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Total Knee Arthroplasty; Knee Disease; Total Knee Replacement; Osteo Arthritis Knee

Keywords

Knee Arthroplasty; Prosthesis; Implants; HLS implants; postero-stabilized prosthesis; third condyle; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Evaluation of long-term survivorship of total knee replacement surgeries with HLS devices

  Implants survival

  10-year

Secondary Outcomes (4)

• Evaluation of clinical performance

  baseline (pre-surgery) to 10-year

• Evaluation of patient satisfaction with the surgery

  time up to 10-year FU

• Radiographic evaluation

  baseline (1-year FU) to 10-year FU

• Evaluation of safety of the study implants

  time up to 10-year FU

Interventions

patient with knee arthroplasty DEVICE

Also known as: patient with HLS prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• For the HLS-1, HLS-2, HLS Evolution and HLS Noetos retrospective group:
• Adult patients older than 18 years old.
• 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.
• Patients who have been informed about their participation into an observational study.
• For the HLS KneeTec prospective group (with retrospective surgeries):
• Adult patients older than 18 years old.
• 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.
• Patients who are willing and able to complete the scheduled FU visits.
• Patients who have been informed about their participation into an observational registry study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corin: lead

Study Sites (1)

Hopital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, 69000, France

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Elvire SERVIEN, MD,PhD

  Service de chirurgie orthopédique. Hopital de la Croix-Rousse, Hospices Civils de Lyon - France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: January 27, 2021
• Study Start: December 15, 2011
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

FR (1)