Clinical trial NCT03035435: Fast-track Rehabilitation After Total Knee or Hip Arthroplasty
Official title: Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty
Hip Arthroplasty
Keywords: fast-track rehabilitation
fast-track surgery
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The recruitment will take place to Rehabilitation Unit of Don Gnocchi Foundation of Rovato (Brescia, Italy), from January 2016 to August 2016. An informed consent will be signed by each participant in agreement with Helsinki Declaration. The study is approved by the local Ethical Committee.

Brief summary: In the last years, a lot of surgical fast track programs (SFTP) have been created and developed. This is due to the steady growing number of interventions on knee and hip; after the surgical treatment, a period of physical rehabilitation (PR) is established to be useful and effective, it usually takes 2-3 weeks. The recovery of strength, range of motion (ROM), independence, the reduction of pain and disability are the aims of PR. With the SFTP and a specific rehabilitation program named fast track rehabilitation (FTR) these times can be reduced. First of all because the length of stay (LOS) it's also caused by organizational problems of the hospitals, not only for the factors related to the patient. It's already been demonstrated that an early mobilization decreases the risk of thromboembolic complications and of pain, furthermore an early rehabilitation increase the patient autonomy and reduces the lost of residual abilities. Moreover a PR program studied for fast track patient will reduce minimum by a 50% the LOS in hospital, decreasing so the sanitary efforts that are always a problem for all the countries. The aim of this study is therefore to propose a fast track rehabilitation program based on an 8 days program for hip and knee arthroplasty being operated with an SFTP.


Eligibility criteria: Inclusion Criteria:

* adult people (\>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb\>9 g/l).

Exclusion Criteria:

* the presence of pain measured with NRS (NRS\>4)
* rheumatoid arthritis, past surgery
* cancer
* neurological and psychiatric disorders
* dementia with Minimental Test\<24
* pregnancy
* participation in the other clinical studies.

Primary outcomes:
measure: International Knee Society Score
timeFrame: Change from Baseline fast-track rehabilitation at 8th and 15th day
measure: Merle D'Aubigne' scale
timeFrame: Change from Baseline fast-track rehabilitation at 8th and 15th day
Secondary outcomes:
measure: Barthel Index
timeFrame: Change from Baseline fast-track rehabilitation at 8th and 15th day
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: Chiara Arienti, PhD(s)
role: PRINCIPAL_INVESTIGATOR
References: