NCT04460989

Brief Summary

The main objective of this study is to evaluate the benefit of personalized prostheses compared to conventional prostheses on patient satisfaction 24 months after total knee arthroplasty.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 27, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

4 years

First QC Date

July 2, 2020

Last Update Submit

June 28, 2024

Conditions

Gonarthrosis

Outcome Measures

Primary Outcomes (1)

  • IKS self-questionnaire Score at M24

    The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.

    24 MONTHS

Secondary Outcomes (3)

  • SF12 score at M24

    24 months

  • KOOS Score at M24

    24 months

  • Forgotten Joint Score at M24

    24 months

Study Arms (2)

standard implant

arthroplasty with a standard implant

Procedure: arthroplasty

personalized implant

arthroplasty with a customized implant

Procedure: arthroplasty

Interventions

arthroplastyPROCEDURE

total knee replacement

personalized implantstandard implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with uni or bilateral primary gonarthrosis

You may qualify if:

  • Adult man or woman who has signed consent to participate in the study
  • Patient with uni- or bilateral primary gonarthrosis
  • For which an indication for total knee arthroplasty has been established

You may not qualify if:

  • History of knee arthroplasty or osteotomy
  • History of knee fracture
  • Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis.
  • Joint or extra-articular deformities of the lower limb of traumatic origin
  • Neurological diseases, stroke sequelae
  • Mental disability or any other reason that may hinder the understanding or strict application of the protocol
  • Patient not affiliated to the French social security scheme
  • Patient under legal protection, guardianship or trusteeship
  • Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months
  • Arthroplasty actually performed
  • Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Orthopédique Santy

Lyon, 69008, France

RECRUITING

Related Publications (2)

  • Beel W, Sappey-Marinier E, Latifi R; ReSurg; Ait-Si-Selmi T, Bonnin MP. Individualised compared to off-the-shelf total knee arthroplasty results in lower and less variable patellar tilt. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3163-3173. doi: 10.1002/ksa.12234. Epub 2024 Jun 12.

    PMID: 38864165DERIVED

  • Sappey-Marinier E, Beel W; ReSurg; Bonnin MP, Ait-Si-Selmi T. Better operating room efficiency and reduced staff demand: Individualised versus off-the-shelf total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2024 Dec;32(12):3174-3184. doi: 10.1002/ksa.12233. Epub 2024 Jun 12.

    PMID: 38864156DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • MICHEL BONNIN, MD

    CENTRE ORTHOPÉDIQUE SANTY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel BONNIN, MD

CONTACT

04 37 53 00 26bonnin.michel@gmail.com

Tarik AIT SI SELMI, MD

CONTACT

04 37 53 07 04tarik.aitsiselmi@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

October 27, 2021

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)