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Fast-track Rehabilitation After Total Knee or Hip Arthroplasty

Sponsor
Fondazione Don Carlo Gnocchi Onlus (Other)
Overall Status
Completed
CT.gov ID
NCT03035435
Collaborator
(none)
58
Enrollment
8
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: fast-track rehabilitation
  • Other: standard care rehabilitation

Study Design

Study Type:
Observational
Actual Enrollment :
58 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
study group

fast-track rehabilitation

Other: fast-track rehabilitation
control group

standard care rehabilitation

Other: standard care rehabilitation

Outcome Measures

Primary Outcome Measures

  1. International Knee Society Score [Change from Baseline fast-track rehabilitation at 8th and 15th day]

  2. Merle D'Aubigne' scale [Change from Baseline fast-track rehabilitation at 8th and 15th day]

Secondary Outcome Measures

  1. Barthel Index [Change from Baseline fast-track rehabilitation at 8th and 15th day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

Investigators

  • Principal Investigator: Chiara Arienti, PhD(s), IRCCS Don Gnocchi Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chiara Arienti, PhD, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier:
NCT03035435
Other Study ID Numbers:
  • Fast Track Rehab
First Posted:
Jan 30, 2017
Last Update Posted:
Jul 26, 2017
Last Verified:
Jul 1, 2017
Keywords provided by Chiara Arienti, PhD, Fondazione Don Carlo Gnocchi Onlus
fast-track rehabilitation
fast-track surgery

Study Results

No Results Posted as of Jul 26, 2017