NCT01671917

Brief Summary

The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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 20, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 4, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2017

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

4 years

First QC Date

July 20, 2012

Last Update Submit

August 29, 2025

Conditions

Knee Osteoarthritis

Keywords

Total knee arthroplastyTotal knee replacementKnee osteoarthritisEducationExerciseHandicapFunctionCost-effectivenessCost-utilityQuality of life

Outcome Measures

Primary Outcomes (2)

  • The percentage of patients able to quit independently the orthopedic department

    Assessed by the ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor at day 4 (± 1 day) after the surgery. Each item will be scored on a 4-class scale (0, unable to perform and 3, able to perform independently). Ability to quite the orthopedic department will be defined as scoring 3 out of 3 for all 4 assessed items on the day of discharge from the orthopedic department.

    at day 4 post-surgery

  • Changes from baseline in functional recovery

    Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery

    6 months post-surgery

Secondary Outcomes (13)

  • Changes from baseline in mean knee pain in the previous 48 hrs

    6 months post-surgery

  • Changes from baseline in mean knee pain in the previous 48 hrs

    12 months post-surgery

  • Changes from baseline in mean function in the previous 48 hrs

    6 months post-surgery

  • Changes from baseline in mean function in the previous 48 hrs

    12 months post-surgery

  • Changes from baseline in mean quality of life

    6 months post-surgery

  • +8 more secondary outcomes

Study Arms (2)

Educational and exercise program

EXPERIMENTAL
Other: Educational and exercise program

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

Educational and exercise programOTHER

* 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement * 4 (twice a week) sessions of an exercise programme lasting 1 hour

Educational and exercise program
Usual careOTHER

Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.

Usual care

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 50 to 85 years
  • Patient suffering from knee osteoarthritis according to ACR for which a total knee arthroplasty is scheduled
  • Preliminary medical examination whose results will be transmitted to the patient
  • Patient giving his informed consent to participate in the study
  • Patient affiliated to or beneficiary of social insurance

You may not qualify if:

  • Patients institutionalized
  • Patients who have already received an ipsilateral total knee arthroplasty
  • Patients with chronic inflammatory arthritis
  • Cognitive or behavioral disorders making assessment impossible
  • Inability to speak and write French
  • TKA indicated for other reason than osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Cochin

Paris, 75014, France

Location

Related Publications (1)

  • Nguyen C, Boutron I, Roren A, Anract P, Beaudreuil J, Biau D, Boisgard S, Daste C, Durand-Zaleski I, Eschalier B, Gil C, Lefevre-Colau MM, Nizard R, Perrodeau E, Rabetrano H, Richette P, Sanchez K, Zalc J, Coudeyre E, Rannou F. Effect of Prehabilitation Before Total Knee Replacement for Knee Osteoarthritis on Functional Outcomes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e221462. doi: 10.1001/jamanetworkopen.2022.1462.

    PMID: 35262716BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • François Rannou, MD, PhD

    AP-HP, Descartes University, INSERM

    PRINCIPAL INVESTIGATOR

  • Pascal Richette, MD, PhD

    CHU Lariboisière

    PRINCIPAL INVESTIGATOR

  • Emmanuel Coudeyre, MD, PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2012

First Posted

August 24, 2012

Study Start

October 4, 2012

Primary Completion

September 22, 2016

Study Completion

November 29, 2017

Last Updated

September 5, 2025

Record last verified: 2025-08

Locations

FR(1)