Open Label Study to Collect Clinical Data to Document Cli... | NCT04727060

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

NCT04727060

Sponsor

Corin

Status

Terminated

Last Update Posted

Jul 16, 2024Actual

Enrollment

2,146Actual

Phase

Not provided

Conditions

Total Knee Arthroplasty
Knee Disease
Total Knee Replacement
Osteo Arthritis Knee

Interventions

patient with knee arthroplasty

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

the clinical data collected to date are sufficient for regulatory requirements

Expanded Access Info

Start Date

Dec 15, 2011Actual

Primary Completion Date

Nov 2023Actual

Completion Date

Nov 2023Actual

First Submitted Date

Nov 2, 2020

First Submission Date that Met QC Criteria

Jan 26, 2021

First Posted Date

Jan 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2024

Last Update Posted Date

Jul 16, 2024Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,146Actual

Name	Type	Description	Arm Group Labels	Other Names
patient with knee arthroplasty	Device			patient with HLS prosthesis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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):

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

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative