Hip OsteoarthritisNCT04199390
Physical Therapy Following Total Hip Arthroplasty
A study testing total hip arthroplasty in people with Hip Osteoarthritis and Surgery, run by Orthopedic One at 1 site in United States.
Trial summary
130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Osteoarthritis, Surgery
- What is being tested?
- total hip arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 7 Oct 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator
- available for follow ups postoperatively
Who cannot join
- Age <18 or > 75
- Preoperative BMI ≥ 40
- Revision (i.e., non-primary) THA procedures
- Patients who have undergone THA in contralateral hip within the past 6 months
- Patient is scheduled for or anticipating THA on contralateral limb within 6 months
- Patients with an active infection (at the time of screening through surgery, as this is a surgical contraindication)
Show all 16Show fewer
- Current co-morbidities such as alcohol or drug addiction, and/or mental disorders could potentially interfere with study participation
- Cognitive deficit or significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
- History of severe osteoporosis, metabolic bone disease, radioactive bone disease, or tumor in the bone surrounding the hip joint
- History of significant neurological and/or musculoskeletal disorders that may adversely affect gait after THA
- History of inflammatory hip arthritis
- History of septic hip arthritis in affected hip
- Patients requiring discharge to a rehabilitation center, skilled nursing facility, long-term care center, or convalescent home
- Non-English speaking
- Unable to give informed consent
- Currently enrolled in another therapeutic study for THA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Home-based Physical Therapy Versus Outpatient Clinic-based Physical Therapy Following Primary Anterior Total Hip Arthroplasty
130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the other study group at their 6-week follow-up visit.
- Conditions
- Hip Osteoarthritis, Surgery
- Being tested
- total hip arthroplasty
- Keywords
- total hip arthroplasty, physical therapy
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplastyProcedure or surgery
Also called physical therapy
each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based Physical Therapy | Active comparator | Not described Receives: Procedure: total hip arthroplasty |
| Home-based Physical Therapy | Active comparator | Not described Receives: Procedure: total hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hip Disability and Osteoarthritis Outcome Scores
Measured: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
Change in SF-12v2 Scores
Measured: preoperative and postoperative 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start31 Jul 2018
- Primary completion7 Oct 2019
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic One
- Sponsor type
- University, hospital or other
- Collaborators
- Medacta USA
- Responsible party
- Principal investigator, Thomas J Ellis, Orthopedic One
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199390
- Sponsor's protocol ID
- 20181607
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8.
PubMed 25714040Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.
PubMed 25765130Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):225-34. doi: 10.1097/01.blo.0000063600.67412.11.
PubMed 12771834Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.
PubMed 18586222Di Monaco M, Vallero F, Tappero R, Cavanna A. Rehabilitation after total hip arthroplasty: a systematic review of controlled trials on physical exercise programs. Eur J Phys Rehabil Med. 2009 Sep;45(3):303-17. Epub 2009 Feb 23.
PubMed 19238130Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80.
PubMed 15577494Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
PubMed 19277807Austin MS, Urbani BT, Fleischman AN, Fernando ND, Purtill JJ, Hozack WJ, Parvizi J, Rothman RH. Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Apr 19;99(8):648-655. doi: 10.2106/JBJS.16.00674.
PubMed 28419032
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Home-based Physical Therapy Versus Outpatient Clinic-based Physical Therapy Following Primary Anterior Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04199390
- Acronym / sponsor ID
- 20181607
- Conditions
- Hip Osteoarthritis, Surgery
- Keywords
- total hip arthroplasty, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Orthopedic OneUniversity, hospital or other
- Collaborators
- Medacta USA
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 13 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.
130 patients undergoing primary unilateral total hip arthroplasty through anterior approach were enrolled and randomized into one of two groups. One group received standard of care clinic-based physical therapy postoperatively (clinic PT) while the other group underwent progressive home-based exercises to do after surgery (home PT). Patient surveys with Hip Osteoarthritis Outcome Scores (HOOS) and SF12v2 scores for both groups were obtained before surgery as well as 6, 14, and 24 weeks postop. Patients had the option to crossover into the other study group at their 6-week follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinic-based Physical Therapy | Active comparator | Procedure: total hip arthroplasty |
| Home-based Physical Therapy | Active comparator | Procedure: total hip arthroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled to undergo primary unilateral anterior total hip arthroplasty for the treatment of arthritis under the care of the Principal investigator
- available for follow ups postoperatively
Key exclusion criteria (16 listed)
- Age <18 or > 75
- Preoperative BMI ≥ 40
- Revision (i.e., non-primary) THA procedures
- Patients who have undergone THA in contralateral hip within the past 6 months
- Patient is scheduled for or anticipating THA on contralateral limb within 6 months
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 |
|---|---|---|
| total hip arthroplastyAlso: physical therapyeach patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively | Procedure or surgery | Clinic-based Physical Therapy, Home-based Physical Therapy |
Primary outcome
Change in Hip Disability and Osteoarthritis Outcome Scores
Time frame: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks
Change in SF-12v2 Scores
Time frame: preoperative and postoperative 24 weeks
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 13 Dec 2019.
- Background: PubMed 25714040Wolford ML, Palso K, Bercovitz A. Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010. NCHS Data Brief. 2015 Feb;(186):1-8.
- Background: PubMed 25765130Ong KL, Lotke PA, Lau E, Manley MT, Kurtz SM. Prevalence and Costs of Rehabilitation and Physical Therapy After Primary TJA. J Arthroplasty. 2015 Jul;30(7):1121-6. doi: 10.1016/j.arth.2015.02.030. Epub 2015 Feb 28.
- Background: PubMed 12771834Kramer JF, Speechley M, Bourne R, Rorabeck C, Vaz M. Comparison of clinic- and home-based rehabilitation programs after total knee arthroplasty. Clin Orthop Relat Res. 2003 May;(410):225-34. doi: 10.1097/01.blo.0000063600.67412.11.
- Background: PubMed 18586222Galea MP, Levinger P, Lythgo N, Cimoli C, Weller R, Tully E, McMeeken J, Westh R. A targeted home- and center-based exercise program for people after total hip replacement: a randomized clinical trial. Arch Phys Med Rehabil. 2008 Aug;89(8):1442-7. doi: 10.1016/j.apmr.2007.11.058. Epub 2008 Jun 30.
- Background: PubMed 19238130Di Monaco M, Vallero F, Tappero R, Cavanna A. Rehabilitation after total hip arthroplasty: a systematic review of controlled trials on physical exercise programs. Eur J Phys Rehabil Med. 2009 Sep;45(3):303-17. Epub 2009 Feb 23.
- Background: PubMed 15577494Berger RA, Jacobs JJ, Meneghini RM, Della Valle C, Paprosky W, Rosenberg AG. Rapid rehabilitation and recovery with minimally invasive total hip arthroplasty. Clin Orthop Relat Res. 2004 Dec;(429):239-47. doi: 10.1097/01.blo.0000150127.80647.80.
- Background: PubMed 19277807Sharma V, Morgan PM, Cheng EY. Factors influencing early rehabilitation after THA: a systematic review. Clin Orthop Relat Res. 2009 Jun;467(6):1400-11. doi: 10.1007/s11999-009-0750-9. Epub 2009 Mar 10.
- Background: PubMed 28419032Austin MS, Urbani BT, Fleischman AN, Fernando ND, Purtill JJ, Hozack WJ, Parvizi J, Rothman RH. Formal Physical Therapy After Total Hip Arthroplasty Is Not Required: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Apr 19;99(8):648-655. doi: 10.2106/JBJS.16.00674.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total hip arthroplasty in people with Hip Osteoarthritis and Surgery, run by Orthopedic One at 1 site 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 2 inclusion and 16 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 13 Dec 2019. 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 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?
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?
Change in Hip Disability and Osteoarthritis Outcome Scores (time frame: preoperative, postoperative 6 weeks, postoperative 12 weeks, and postoperative 24 weeks). 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?
On the ClinicalTrials.gov record for NCT04199390, which also lists 8 linked publications.
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 13 Dec 2019.