Hip ArthritisNCT04492462
The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
A study testing Formal Physical Therapy and Self-directed Physical Therapy in people with Hip Arthritis and Total Hip Arthroplasty, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hip Arthritis, Total Hip Arthroplasty
- What is being tested?
- Formal Physical Therapy and Self-directed Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2019to 31 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 80 years of age
- Patients undergoing primary anterior total hip arthroplasty for the diagnosis of osteoarthritis
- Patients with no previous invasive hip surgery (such as a previous hip replacement)
Who cannot join
- Non-English speaking persons will be excluded in our study.
- Patients with a recent history (<1 year) of heart attack, stroke, and lung clots.
- Previous invasive surgery on the hip undergoing replacement
- Patients with dementia, Parkinson's, or other neurological disorders
- Non-ambulatory patients
- Patients with impaired ability to consent, whether because of mental illness or otherwise
- Patients being discharged to a rehabilitation center
- Patients that experience intra-operative complications
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University Orthopaedic Associates
Somerset, New Jersey, 08873
Stephen Kayiaros, MD, 732-537-0909
Stephen Kayiaros, MD
- Recruiting
Robert Wood Johnson Somerset Hospital
Somerville, New Jersey, 08876
Daniel C Mascarenhas, MD, 732-235-7869
About this study
This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. They will see a physical therapist in a physical therapy office after their surgery. Here, the therapist will work with the patient to strengthen muscles and improve their walking. The second group, the "Self-directed Physical Therapy" group, will undergo physical therapy in the comfort of their own home using common household items (chairs, steps, etc). These patients will be given a list of exercises and stretches to perform on their own. It is our goal to prove that formal physical therapy is not needed after anterior hip replacements.
- Conditions
- Hip Arthritis, Total Hip Arthroplasty
- Being tested
- Formal Physical Therapy, Self-directed Physical Therapy
- Keywords
- Total Hip Arthroplasty, Anterior Approach, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formal Physical TherapyOther
Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
Self-directed Physical TherapyOther
Patients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office
| Study group | Role | What they receive |
|---|---|---|
| Formal Physical Therapy | Experimental | Not described Receives: Other: Formal Physical Therapy |
| Self-directed Physical Therapy | Experimental | Not described Receives: Other: Self-directed Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change inHarris Hip Score (HHS)
elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result
Measured: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Secondary outcomes (3)
Change in timed up and go test
Patients will be assessed the amount of time it takes for them rise from a standard arm chair, walk 10 feet on the floor at normal pace, and then return and site down in same standard arm chair. Duration to complete task will be recorded in seconds
Measured: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Change in Visual Analog Scale for Pain
Patients will rate their pain on a scale form 0-10 at a given time point with 0 being no pain and 10 being unbearable pain. The higher the number, the more pain
Measured: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form
Self-administered health survey that assesses pain, stiffness, and function of arthritis of the hip or knee. WOMAC form assesses activities of daily living, functional mobility, gait, general health, pain, and quality of life. WOMAC questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). A total score of 0 to 96 is possible, with a lower score indicating less pain or disability.
Measured: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start22 Oct 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Kayiaros MD, Rutgers, The State University of New Jersey
- Investigators
- Stephen T Kayiaros, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492462
- Sponsor's protocol ID
- Pro20140001090
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT04492462
- Acronym / sponsor ID
- Pro20140001090
- Conditions
- Hip Arthritis, Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Anterior Approach, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jul 2020 (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.
This study will look to determine two different types of physical therapy regimens in patients who undergo anterior total hip replacement. We will compare the results of two groups. The first group, the "Formal Physical Therapy" group, will undergo standard physical therapy following their surgery. They will see a physical therapist in a physical therapy office after their surgery. Here, the therapist will work with the patient to strengthen muscles and improve their walking. The second group, the "Self-directed Physical Therapy" group, will undergo physical therapy in the comfort of their own home using common household items (chairs, steps, etc). These patients will be given a list of exercises and stretches to perform on their own. It is our goal to prove that formal physical therapy is not needed after anterior hip replacements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formal Physical Therapy | Experimental | Other: Formal Physical Therapy |
| Self-directed Physical Therapy | Experimental | Other: Self-directed Physical Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 18 and 80 years of age
- Patients undergoing primary anterior total hip arthroplasty for the diagnosis of osteoarthritis
- Patients with no previous invasive hip surgery (such as a previous hip replacement)
Key exclusion criteria (8 listed)
- Non-English speaking persons will be excluded in our study.
- Patients with a recent history (<1 year) of heart attack, stroke, and lung clots.
- Previous invasive surgery on the hip undergoing replacement
- Patients with dementia, Parkinson's, or other neurological disorders
- Non-ambulatory patients
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 |
|---|---|---|
| Formal Physical TherapyPatients will undergo standard physical therapy following their surgery with a physical therapist in an office | Other | Formal Physical Therapy |
| Self-directed Physical TherapyPatients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office | Other | Self-directed Physical Therapy |
Primary outcome
Change inHarris Hip Score (HHS)
Time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
elf-administered health survey that assesses pain, function, absence of deformity, and range of motion of the hip through 10 questions. HHS measures dysfunction, so a higher score indicates a better, higher functional outcome. Less than 70 is poor result, 70-80 ia fair result, 80-90 is good result, 90-100 is excellent result
3 secondary outcomes
Change in timed up and go test
Time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Change in Visual Analog Scale for Pain
Time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) form
Time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: Yes
Related trials for Hip Arthritis
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Active, not recruiting
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty
Arthritis Knee, Arthritis Hip
Recruiting
FRONT Block for Quality of Recovery After Total Hip Arthroplasty
Osteoarthritis of the Hip, Postoperative Pain
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.
Stephen T Kayiaros, MD principal investigator
Rutgers University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formal Physical Therapy and Self-directed Physical Therapy in people with Hip Arthritis and Total Hip Arthroplasty, run by Rutgers, The State University of New Jersey at 2 sites in United States.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Mascarenhas, MD (732-235-7869, daniel.mascarenhas@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change inHarris Hip Score (HHS) (time frame: assessed 1,3,6, and 12 months after total hip replacement to assess change at each time point following surgery). 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 16 Sep 2021.