Knee ArthroplastyNCT03035435
Fast-track Rehabilitation After Total Knee or Hip Arthroplasty
An observational study of Knee Arthroplasty and Hip Arthroplasty, run by Fondazione Don Carlo Gnocchi ETS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Arthroplasty, Hip Arthroplasty
- What is being tested?
- fast-track rehabilitation
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).
Who cannot join
- 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.
About this study
Official title: Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study
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
- Being tested
- fast-track rehabilitation, standard care rehabilitation
- Keywords
- fast-track rehabilitation, fast-track surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast-track rehabilitationOther
standard care rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| study group | fast-track rehabilitation Receives: Other: fast-track rehabilitation | |
| control group | standard care rehabilitation Receives: Other: standard care rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Society Score
Measured: Change from Baseline fast-track rehabilitation at 8th and 15th day
Merle D'Aubigne' scale
Measured: Change from Baseline fast-track rehabilitation at 8th and 15th day
Secondary outcomes (1)
Barthel Index
Measured: Change from Baseline fast-track rehabilitation at 8th and 15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Arienti, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Chiara Arienti, PhD(s), Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035435
- Sponsor's protocol ID
- Fast Track Rehab
- Status last verified
- Jul 2017
- First submitted
- 17 Jan 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-track Rehabilitation After Total Knee or Hip Arthroplasty: an Observational Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT03035435
- Acronym / sponsor ID
- Fast Track Rehab
- Conditions
- Knee Arthroplasty, Hip Arthroplasty
- Keywords
- fast-track rehabilitation, fast-track surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: fast-track rehabilitationfast-track rehabilitation |
| control group | – | Other: standard care rehabilitationstandard care rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult people (>18 years), both sex, admitted for elective total knee or hip arthroplasty, with a clinical stability (Hb>9 g/l).
Key exclusion criteria (7 listed)
- the presence of pain measured with NRS (NRS>4)
- rheumatoid arthritis, past surgery
- cancer
- neurological and psychiatric disorders
- dementia with Minimental Test<24
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast-track rehabilitation | Other | study group |
| standard care rehabilitation | Other | control group |
Primary outcome
International Knee Society Score
Time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
Merle D'Aubigne' scale
Time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
1 secondary outcome
Barthel Index
Time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Related trials for Knee Arthroplasty
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Active, not recruiting
ATTUNE Revision System in the Revision Total Knee Arthroplasty Population
Revision Total Knee Arthroplasty
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Not yet recruiting
Patient Satisfaction After Robotic-Assisted Versus Conventional Total Knee Arthroplasty
Osteoarthritis (Knee), Robotic Assisted Arthroplasty
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Arienti, PhD(s) principal investigator
IRCCS Don Gnocchi Foundation
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthroplasty and Hip Arthroplasty, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Society Score (time frame: Change from Baseline fast-track rehabilitation at 8th and 15th day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.