Hip OsteoarthritisFastTrack-HNCT04211987
Fast Track Total Hip Arthroplasty vs Standard Care
A study testing fast track care protocol in people with Hip Osteoarthritis and Hip Pain Chronic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Hip Pain Chronic
- What is being tested?
- fast track care protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2018to 25 Jan 2021
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
- BMI < 32
- American Society of Anesthesiologists physical status classification system (ASA) </= 2
- preoperative hemoglobin (HB) >13 g/dl
- patients eligible for spinal anesthesia
- presence of a care-giver
Who cannot join
- psychiatric diseases
- preoperative use of crutches
- ASA > 3
- preoperative HB < 13 g/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial
Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.
Read the detailed description
The aim of this protocol is to compare standard care and fast track total hip arthroplasties. The fast track care consists of:
- preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
- antalgic protocol administered only orally
- early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position. The standard care consists of usual antalgic and physiotherapy post-operative care:
- Antalgic protocol consist in intravenous drugs
- the first physiotherapy session is the day after surgery
- Conditions
- Hip Osteoarthritis, Hip Pain Chronic
- Being tested
- fast track care protocol, standard care protocol
- Keywords
- fast track care, Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast track care protocolProcedure or surgery
fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
standard care protocolProcedure or surgery
standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
| Study group | Role | What they receive |
|---|---|---|
| Fast track care protocol | Active comparator | patients treated using fast track care protocol Receives: Procedure: fast track care protocol |
| Standard care protocol | Active comparator | patients treated using standard care protocol Receives: Procedure: standard care protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early functional outcomes
Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day.
This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.
Measured: Third post operative day
Secondary outcomes (9)
hospital staying
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days
Measured: Third post operative day
Harris Hip Score (HHS)
The collection of functional outcomes score HHS at 6 weeks. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
The collection of functional outcomes score HHS at 6 weeks. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
The collection of functional outcomes score HHS at 6 weeks. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 6 weeks after surgery
Harris Hip Score (HHS)
The collection of functional outcomes score HHS at 3 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results
Measured: 3 months after surgery
Harris Hip Score (HHS)
The collection of functional outcomes score HHS at 6 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 6 months after surgery
Harris Hip Score (HHS)
The collection of functional outcomes score HHS at 12 month after surgery. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 as poor result; 70-80 as fair, 80-90 as good, and 90-100 as excellent results.
Measured: 12 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The collection of functional outcomes score Womac at 6 weeks after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 6 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The collection of functional outcomes score Womac at 3 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 3 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The collection of functional outcomes score Womac at 6 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 6 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The collection of functional outcomes score Womac at 12 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The collection of functional outcomes score Womac at 12 months after surgery. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start13 Mar 2018
- Primary completion31 Dec 2020
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dante Dallari, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211987
- Sponsor's protocol ID
- 14-19
- Acronym
- FastTrack-H
- Status last verified
- May 2023
- First submitted
- 23 Dec 2019
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Rehabilitation Fast Track Total Hip Arthroplasty vs Standard Care: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04211987
- Acronym / sponsor ID
- FastTrack-H / 14-19
- Conditions
- Hip Osteoarthritis, Hip Pain Chronic
- Keywords
- fast track care, Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 26 Dec 2019 (actual)
- 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.
Fast-track total hip arthroplasty (THA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total hip arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.
Detailed description
The aim of this protocol is to compare standard care and fast track total hip arthroplasties. The fast track care consists of:
- preoperative educational lesson in which orthopedic surgeon, anesthesiologist and physiotherapist illustrate the operative and post operative path to the patients
- antalgic protocol administered only orally
- early rehabilitation care. The day of the surgical operation, the physiotherapist helps the patient reach the upright position. The standard care consists of usual antalgic and physiotherapy post-operative care:
- Antalgic protocol consist in intravenous drugs
- the first physiotherapy session is the day after surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast track care protocol | Active comparator | Procedure: fast track care protocolpatients treated using fast track care protocol |
| Standard care protocol | Active comparator | Procedure: standard care protocolpatients treated using standard care protocol |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
- BMI < 32
- American Society of Anesthesiologists physical status classification system (ASA) </= 2
- preoperative hemoglobin (HB) >13 g/dl
- patients eligible for spinal anesthesia
Key exclusion criteria (4 listed)
- psychiatric diseases
- preoperative use of crutches
- ASA > 3
- preoperative HB < 13 g/dl
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 care protocolfast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol. | Procedure or surgery | Fast track care protocol |
| standard care protocolstandard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol. | Procedure or surgery | Standard care protocol |
Primary outcome
Early functional outcomes
Time frame: Third post operative day
Early functional outcomes are collecting using Lowa Level of Assistance(ILOA) during the third post-operative day. This scale is able to provide data on the autonomy reached by the patient in the first postoperative period going to investigate five main motor activities (get up from supine to seated, from sitting to standing position, walk around, take three steps, the speed of walking). the total score can vary from 0 to 50, where 50 indicates better functional results.
9 secondary outcomes
hospital staying
Time frame: Third post operative day
Harris Hip Score (HHS)
Time frame: 6 weeks after surgery
Harris Hip Score (HHS)
Time frame: 3 months after surgery
Harris Hip Score (HHS)
Time frame: 6 months after surgery
Harris Hip Score (HHS)
Time frame: 12 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months after surgery
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 24 May 2023.
Related trials for Hip Osteoarthritis
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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.
Dante Dallari principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast track care protocol in people with Hip Osteoarthritis and Hip Pain Chronic, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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 6 inclusion and 4 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early functional outcomes (time frame: Third post operative day). 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 24 May 2023.