Clinical trial NCT01747759: Evaluation of a Preoperative Education in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis (Knee OA)
Keywords: • Knee osteoarthritis
Total knee arthroplasty
Selfcare
Booklet
Rehabilitation
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2012-12-12
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ranging from 55 to 75 Planned total knee arthroplasty

Exclusion Criteria:

* 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

Primary outcomes:
measure: knowledge score
timeFrame: at day 1
Secondary outcomes:
measure: pain
timeFrame: Baseline
measure: Primary disability
timeFrame: Baseline
measure: Duration of hospitalization surgery
timeFrame: at day 1
measure: Transfer rate in acute care and rehabilitation, and length of stay
timeFrame: at week 6
measure: Patient's overall satisfaction towards the information received
timeFrame: at week 6
measure: Patient's confidence in its own ability to achieve rehabilitation
timeFrame: at day-1
measure: Patient's knowledge and beliefs about his condition
timeFrame: Baseline, at day-1 and week 6
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Stephane DESCAMPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.