NCT01747759

Brief Summary

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations. Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards. To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test. The study protocol was approved by the local Ethic Committee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

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

Study Start

First participant enrolled

November 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

December 10, 2012

Last Update Submit

August 5, 2026

Conditions

Knee Osteoarthritis (Knee OA)

Keywords

Total knee arthroplastySelfcareBookletRehabilitationKnee oesteoarthritis

Outcome Measures

Primary Outcomes (1)

  • knowledge score

    at day 1

Secondary Outcomes (7)

  • pain

    Baseline

  • Primary disability

    Baseline

  • Duration of hospitalization surgery

    at day 1

  • Transfer rate in acute care and rehabilitation, and length of stay

    at week 6

  • Patient's overall satisfaction towards the information received

    at week 6

  • +2 more secondary outcomes

Study Arms (2)

Kruskal-Wallis and qualitative parameters

OTHER

The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test

Other: Kruskal-Wallis and qualitative parameters

Fisher exact test

OTHER

The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test

Other: Kruskal-Wallis and qualitative parameters

Interventions

Kruskal-Wallis and qualitative parametersOTHER
Fisher exact testKruskal-Wallis and qualitative parameters

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranging from 55 to 75 Planned total knee arthroplasty

You may not qualify if:

  • Age under 55 or above 75 Patients institutionalized Patients who have received a total knee arthroplasty of the ipsilateral knee Patient not affiliated to a social security scheme (beneficiary or assignee) Patients with chronic inflammatory rheumatism Cognitive and behavioral issues Disorders of understanding and expression of the French language TKR on complex knee

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Eschalier B, Descamps S, Pereira B, Vaillant-Roussel H, Girard G, Boisgard S, Coudeyre E. Randomized blinded trial of standardized written patient information before total knee arthroplasty. PLoS One. 2017 Jul 5;12(7):e0178358. doi: 10.1371/journal.pone.0178358. eCollection 2017.

    PMID: 28678854RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Stephane DESCAMPS

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2012

First Posted

December 12, 2012

Study Start

November 1, 2010

Primary Completion

August 1, 2011

Study Completion

March 1, 2012

Last Updated

August 10, 2026

Record last verified: 2026-08

Locations

FR(1)