Knee Osteoarthritis (Knee OA) Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04833946 -
To Assess the Effect of 336 Days Exposure of Paractin® on Pain & Disease Progression in Patients Suffering From Osteoarthritis of Knee Joint.
|
N/A |