Fast-track Rehabilitation After Total Knee or Hip Arthroplasty

NCT03035435 | Completed

• 1 other identifier: Fast Track Rehab
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Arthroplasty; Hip Arthroplasty

Keywords

fast-track rehabilitation; fast-track surgery

Outcome Measures

Primary Outcomes (2)

• International Knee Society Score

  Change from Baseline fast-track rehabilitation at 8th and 15th day

• Merle D'Aubigne' scale

  Change from Baseline fast-track rehabilitation at 8th and 15th day

Secondary Outcomes (1)

• Barthel Index

  Change from Baseline fast-track rehabilitation at 8th and 15th day

Study Arms (2)

study group

fast-track rehabilitation

Other: fast-track rehabilitation

control group

standard care rehabilitation

Other: standard care rehabilitation

Interventions

fast-track rehabilitation OTHER

study group

standard care rehabilitation OTHER

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Officials

• Chiara Arienti, PhD(s)

  IRCCS Don Gnocchi Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 30, 2017
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 26, 2017

Record last verified: 2017-07