NCT06676189

Brief Summary

The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2024

Typical duration for not_applicable

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

Study Progress74%
Jun 2024Mar 2027

Study Start

First participant enrolled

June 4, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 17, 2025

Status Verified

October 1, 2024

Enrollment Period

2.7 years

First QC Date

October 24, 2024

Last Update Submit

January 16, 2025

Conditions

Total Knee ReplacementPrimary Knee ReplacementGonarthrosis

Keywords

prospectiverandomized studyparallel groupsforgotten joint score

Outcome Measures

Primary Outcomes (2)

  • evaluation of the forgotten joint score (FJS12)

    Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies

    Day 45

  • evaluation of the forgotten joint score (FJS12)

    Forgotten knee score at 6 weeks (FJS-12, evaluated out of 100), which allows the analysis of quality of life specifically in relation to knee pathologies

    Month 12

Secondary Outcomes (16)

  • knee joint mobility

    Day -1

  • knee joint mobility

    Day 45

  • knee joint mobility

    month 12

  • pain assessment

    Day -1

  • pain assessment

    day 45

  • +11 more secondary outcomes

Study Arms (2)

medial pivot polyethylene

ACTIVE COMPARATOR

Total knee replacement with medial pivot polyethylene

Device: total knee arthroplasty with medial pivot polyethylene

ultra-congruent polyethylene

ACTIVE COMPARATOR

Total knee replacement with ultra-congruent polyethylene

Device: total knee arthroplasty with ultra-congruent polyethylene

Interventions

total knee arthroplasty with medial pivot polyethyleneDEVICE

total knee arthroplasty with medial pivot polyethylene

medial pivot polyethylene
total knee arthroplasty with ultra-congruent polyethyleneDEVICE

total knee arthroplasty with ultra-congruent polyethylene

ultra-congruent polyethylene

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects 18 to 90 years of age, eligible for a primary total knee replacement for gonarthrosis
  • Competent subjects able to give informed consent to participate in the research
  • Affiliation to the social security system

You may not qualify if:

  • Infection history of the knee to be replaced
  • Deformity greater than 15 degrees
  • Any surgical and/or anesthetic contraindication, or any condition deemed by the investigator to be incompatible with the research.
  • Any contraindication mentioned in the instructions for use of the medical device
  • Pregnant or breastfeeding women
  • Recent infection history of the surgical site
  • Adults who are subject to a legal protection measure or who are unable to express their constent (Article L1121-8 of the French Public Health Code) and subjects under judicial protection (article L. 1122-2 FPHC)
  • Subjects who refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Stéphane DESCAMPS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Arm 1: Total knee replacement with medial pivot polyethylene Arm 2: Total knee replacement with ultra-congruent polyethylene
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

November 6, 2024

Study Start

June 4, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 17, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)