Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)

NCT05211141 | Terminated

• 1 other identifier: CSP2017-07
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice

Conditions

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

Keywords

Knee Arthroplasty; Prosthesis; ultracongruent prosthesis; Implants; HLS implants; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Evaluation of implant survival in subjects receiving a total knee arthroplasty with the HLS KneeTec Deep Dish up to 10 years after the surgery

  kaplan Meier survival rate

  10-year

Secondary Outcomes (7)

• Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery

  preoperatively, 15 months, 5 years and 10 years

• Evaluation of functional performance of the HLS KneeTec Deep Dish after the surgery

  15 months, 5 years and 10 years

• Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery

  preoperatively, 15 months, 5 years and 10 years

• Evaluation of clinical performance of the HLS KneeTec Deep Dish after the surgery

  15 months, 5 years and 10 years

• radiographic evaluation of the performance of HLS KneeTec Deep Dish

  preoperatively up to 10 years

Study Arms (1)

Patient with knee arthroplasty

patient with HLS KneeTec Deep Dish prosthesis

Device: HLS KneeTec Deep Dish

Interventions

HLS KneeTec Deep Dish DEVICE

total knee arthroplasty with HLS KneeTec Deep Dish prosthesis

Patient with knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients treated with HLS KneeTec Deep Dish 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:

• Male or female aged 18 - 80 years old at the time of the surgery
• Implanted with an HLS KneeTec Deep Dish TKP according to the Instructions for Use (IFU) after the 1st of february, 2017
• Patients agree to consent to collect data from their medical records and agree to answer questionnaires for the purposes of the study.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Corin: lead

Study Sites (1)

Chru de Nancy

Nancy, 54000, France

Location

Study Officials

• Olivier ROCHE, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 27, 2022
• Study Start: February 28, 2017
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

FR (1)