Hip OsteoarthritisFastTrack-HNCT03875976
Total Hip Arthroplasty: Fast Track Protocol is the Future?
A study testing Fast Track Protocol in people with Hip Osteoarthritis and Arthropathy of Hip, 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, Arthropathy of Hip
- What is being tested?
- Fast Track Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 1 Jan 2023
- 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
- Time up ang go test </= 12 seconds
- 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: Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on Functional Outcomes and Hospital Stay Of Total Hip Arthroplasty
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, Arthropathy of Hip
- Being tested
- Fast Track 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 ProtocolProcedure or surgery
Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain 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 Protocol | Active comparator | Patients treated using Fast Track Care Protocol Receives: Procedure: Fast Track Protocol |
| Standard 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 56, where 56 indicates worst functional results.
Measured: Third post operative day
Secondary outcomes (12)
hospital staying
The collection of hospital stay for each patient. The fast track expecting hospital stay is three days.
Measured: Third post operative day
Incidence of early major complications
The collection of acute infection and early fracture
Measured: Third day after surgery
Number of transfusions
the collection of number of transfusions during hospital staying
Measured: Third day after surgery
Analgesic consumption
The request for analgesic rescue in relation to fast track standard analgesic scheme
Measured: Third day after surgery
Harris Hip Score (HHS) at 6 weeks
The collection of functional outcomes HHS at 6 weeks. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes.
Measured: 6 weeks after surgery
Harris Hip Score (HHS) at third month
The collection of functional outcomes HHS at third month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes
Measured: third month after surgery
Harris Hip Score (HHS) at sixth month
The collection of functional outcomes HHS at sixth month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes
Measured: sixth month after surgery
Harris Hip Score (HHS) at twelfth month twelfth
The collection of functional outcomes HHS at twelfth month. The HHS is made of four subscales. The first is pain, which measures pain severity (44 points); function, which is made up of daily activities and gait (47 points); the absence of deformity, which is a subscale that measures hip flexion, adduction, internal rotation, leg length discrepancy and range of motion measures.(4 points), and range of motion (5 points). The higher scores representing less dysfunction and better outcomes
Measured: twelfth month after surgery
WOMAC at 6 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes.
Measured: 6 weeks after surgery
WOMAC at third month
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes.
Measured: Third month after surgery
WOMAC at sixth month
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes.
Measured: Sixth month after surgery
WOMAC at twelfth month
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales:
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher scores representing less outcomes.
Measured: twelfth month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Mar 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- 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
- Model description
- The study aims to evaluate the effectiveness of a fast track protocol , which consists of an innovative analgesic therapy scheme and a rapid rehabilitation protocol, and a standard care protocol.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dante Dallari, MD, Istituto Ortopedico Rizzoli
- Investigators
- Dante Dallari, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875976
- Sponsor's protocol ID
- 11269
- Acronym
- FastTrack-H
- Status last verified
- Jul 2023
- First submitted
- 13 Mar 2019
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rocchi M, Stagni C, Govoni M, Mazzotta A, Vivarelli L, Orlandi Magli A, Perrone M, Benedetti MG, Dallari D. Comparison of a fast track protocol and standard care after hip arthroplasty in the reduction of the length of stay and the early weight-bearing resumption: study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):348. doi: 10.1186/s13063-021-05314-5.
PubMed 34001185
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study Comparing Fast Track and Standard Care Protocol on Functional Outcomes and Hospital Stay Of Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03875976
- Acronym / sponsor ID
- FastTrack-H / 11269
- Conditions
- Hip Osteoarthritis, Arthropathy of Hip
- Keywords
- fast track care, total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 15 Mar 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
- Model description
- The study aims to evaluate the effectiveness of a fast track protocol , which consists of an innovative analgesic therapy scheme and a rapid rehabilitation protocol, and a standard care protocol.
| Arm | Type | Receives |
|---|---|---|
| Fast Track Protocol | Active comparator | Procedure: Fast Track ProtocolPatients treated using Fast Track Care Protocol |
| Standard 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 (7 listed)
- patients affected by hip osteoarthritis, eligible for primary total hip arthroplasty
- BMI < 32
- Time up ang go test </= 12 seconds
- American Society of Anesthesiologists physical status classification system (ASA) </= 2
- preoperative hemoglobin (HB) >13 g/dl
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 ProtocolFast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol | Procedure or surgery | Fast Track 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 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 56, where 56 indicates worst functional results.
12 secondary outcomes
hospital staying
Time frame: Third post operative day
Incidence of early major complications
Time frame: Third day after surgery
Number of transfusions
Time frame: Third day after surgery
Analgesic consumption
Time frame: Third day after surgery
Harris Hip Score (HHS) at 6 weeks
Time frame: 6 weeks after surgery
Harris Hip Score (HHS) at third month
Time frame: third month after surgery
Harris Hip Score (HHS) at sixth month
Time frame: sixth month after surgery
Harris Hip Score (HHS) at twelfth month twelfth
Time frame: twelfth month after surgery
WOMAC at 6 weeks
Time frame: 6 weeks after surgery
WOMAC at third month
Time frame: Third month after surgery
WOMAC at sixth month
Time frame: Sixth month after surgery
WOMAC at twelfth month
Time frame: twelfth month 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 21 Jul 2023.
- Derived from this study: PubMed 34001185Rocchi M, Stagni C, Govoni M, Mazzotta A, Vivarelli L, Orlandi Magli A, Perrone M, Benedetti MG, Dallari D. Comparison of a fast track protocol and standard care after hip arthroplasty in the reduction of the length of stay and the early weight-bearing resumption: study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):348. doi: 10.1186/s13063-021-05314-5.
- Individual participant dataSharing planned: Yes
Related trials for Hip Osteoarthritis
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
RecruitingObservational study
Post-Market Clinical Follow-up of Intra-Articular Hyaluronic Acid in Hip Osteoarthritis
Hip OA
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
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, MD 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 Protocol in people with Hip Osteoarthritis and Arthropathy of Hip, 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 7 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 21 Jul 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?
On the ClinicalTrials.gov record for NCT03875976, which also lists 1 linked publication.
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 21 Jul 2023.