Osteoarthritis of HipHIPPRECAUNCT03341442

A Study of Posterior Hip Precautions After Total Hip Arthroplasty

A study testing No hip precautions in people with Osteoarthritis of Hip, run by West Virginia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Osteoarthritis of Hip
What is being tested?: No hip precautions
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 321 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Jun 2020
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

scheduled for elective, primary, osteoarthritic total hip arthroplasty via a posterolateral approach

Who cannot join

< 18 years of age, cognitive disorders, neuromuscular spasticity disorders, femoral neck fractures, connective tissue disorders (ie Ehlers Danlos), alcohol abuse, dual mobility implant, constrained implants, pregnant or planning to become pregnant at time of consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

WVU Medicine Department of Orthopaedics
Morgantown, West Virginia, 26506

Other trials in United States

About this study

Official title: Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty

The purpose of this study is to perform a randomized controlled study to compare patients undergoing THA via a posterolateral approach to receive either standard of care post-surgery hip restrictions or to receive no restrictions. The investigators goal is to first complete a pilot study in which the investigators assess the short term dislocation rates 3-6 months and then continue to recruit into this study and follow these patients for a year to determine the 1 year risk for dislocation. The investigators also will compare the HOOS Jr. and VAS scores and time until free from walking aid. The research question is: Will the elimination of post operative posterior hip precautions increase the dislocation rate? The hypothesis is that the elimination of post operative hip precautions will not increase the dislocation rate.

Read the detailed description

Participants at the following institutions (West Virginia University; The Andrews Institute; and University of Kentucky Healthcare Sports Medicine will be given an educational session regarding hip replacement and procedures to follow after total hip replacement at their History and Physical visit prior to elective total hip replacement surgery via a posterior approach. 2. Participants will be told of the study after their educational session. All their questions will be answered and they will be given the opportunity to consent for participation. 3. After consent, the participant will be randomized to a control group receiving Standard of Care (education) hip precautions or to a 'no hip precautions' group. The control group will be instructed to practice postoperative hip precautions they learned at their educational session; (standard of care) (no flexion > 90 degrees, no internal rotation, no adduction) for 6 weeks. The intervention group will be aware of the precautions but will be told not to practice them post-operatively. 4. The participants will be monitored per the surgeons' normal routine post-operatively, which includes notification to the surgeon if the subject returns to the hospital with any hip problems. 5. After the first three participants who were randomized to 'no precautions' have returned for their post-op visit at all sites, the DSMB will have a teleconference to discuss any adverse events including dislocations. If any of the first 3 participants dislocated the study will be stopped. 6. At six weeks the following will be recorded: time to elimination of walking aids, dislocation episodes requiring closed reduction, and need for revision surgery. If any of the first 3 intervention participants dislocated during the 6 week period, the study will be stopped. 7. The participants will be asked to complete the HOOS Jr. and VAS follow-up questions at 2-week, 6-week, 3 month, 6 month and one year post-operatively per standard of care follow-up. Participants will be asked to list any hip precautions practiced at these time frames. 8. If the participants fail to come for the standard of care follow up appointments, the research assistant will call the participants and ask the HOOS Jr. and VAS questionnaires over the phone and to list any hip precautions they practiced.

Conditions: Osteoarthritis of Hip
Being tested: No hip precautions
Medical subject headings: Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No hip precautionsProcedure or surgery
No hip precautions practiced after THA surgery

Study groups in NCT03341442
Study group	Role	What they receive
No hip precautions	Experimental	No hip precautions practiced after THA surgery Receives: Procedure: No hip precautions
Hip precautions	No intervention	Hip precautions practiced per standard of care after THA surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Dislocation Rate
Occurrence of dislocations will be compared between groups.
Measured: up to 1 year post op

Secondary outcomes (4)

HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)
Change in baseline score over time will be compared between groups. This is a six question form asked at Pre-op, 2 week, 6 week, 3-6 month, and 1 year post op
Measured: up to 1 year post op
Visual Analog Scale (VAS)
Change in baseline Visual Analog Scale (VAS) over time will be compared between groups. This scale is from 0-100, where 100 is the best, evaluating the patients Health State and will be given at Pre-op, 2 week, 6 week, 3-6 month, and 1 year post op
Measured: up to 1 year post op
Time free from walking aid
Time taken to be free from walking aids will be used to identify differences between groups. This will be evaluated by the provider at 6 weeks, 3/6 months, and 1 year post op
Measured: up to 1 year post op
Hip Precautions Practiced
Hip precautions practiced per patient postoperatively will be compared between groups to identify change in dislocation rates. Patients will be asked at 2 \& 6 week post op what if any precautions they practiced.
Measured: up to 6 week post-op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Jun 2020

First posted14 Nov 2017
Study startApr 2016
Primary completionApr 2019
Study completionJun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Osteoarthritis of HipStudies of the same condition, open and under way.
More trials run by West Virginia UniversityThe 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: 321 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03341442
Sponsor's protocol ID: 1512934414
Acronym: HIPPRECAU
Status last verified: Aug 2020
First submitted: 25 Oct 2017
Last updated: 7 Aug 2020
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No: Individual data will not be available. Group data will be published.

Publications

Austrailian Orthopaedic Association National Joint Replacement Registry., Annual Report. 2012
Hummel MT, Malkani AL, Yakkanti MR, Baker DL. Decreased dislocation after revision total hip arthroplasty using larger femoral head size and posterior capsular repair. J Arthroplasty. 2009 Sep;24(6 Suppl):73-6. doi: 10.1016/j.arth.2009.04.026. Epub 2009 Jul 4.
PubMed 19577890
Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
PubMed 15469226
Suh KT, Park BG, Choi YJ. A posterior approach to primary total hip arthroplasty with soft tissue repair. Clin Orthop Relat Res. 2004 Jan;(418):162-7. doi: 10.1097/00003086-200401000-00026.
PubMed 15043109
Ali Khan MA, Brakenbury PH, Reynolds IS. Dislocation following total hip replacement. J Bone Joint Surg Br. 1981;63-B(2):214-8. doi: 10.1302/0301-620X.63B2.7217144.
PubMed 7217144
Khatod M, Barber T, Paxton E, Namba R, Fithian D. An analysis of the risk of hip dislocation with a contemporary total joint registry. Clin Orthop Relat Res. 2006 Jun;447:19-23. doi: 10.1097/01.blo.0000218752.22613.78.
PubMed 16741469
Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.
PubMed 9917607
Phillips CB, Barrett JA, Losina E, Mahomed NN, Lingard EA, Guadagnoli E, Baron JA, Harris WH, Poss R, Katz JN. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003 Jan;85(1):20-6. doi: 10.2106/00004623-200301000-00004.
PubMed 12533567
Schmidt-Braekling T, Waldstein W, Akalin E, Benavente P, Frykberg B, Boettner F. Minimal invasive posterior total hip arthroplasty: are 6 weeks of hip precautions really necessary? Arch Orthop Trauma Surg. 2015 Feb;135(2):271-274. doi: 10.1007/s00402-014-2146-x. Epub 2015 Jan 4.
PubMed 25556661
Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640.
PubMed 26328242
Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.
PubMed 21076896
Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.
PubMed 23523485
Graves SC, Dropkin BM, Keeney BJ, Lurie JD, Tomek IM. Does Surgical Approach Affect Patient-reported Function After Primary THA? Clin Orthop Relat Res. 2016 Apr;474(4):971-81. doi: 10.1007/s11999-015-4639-5. Epub 2015 Nov 30.
PubMed 26620966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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All Osteoarthritis of Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT03341442
Acronym / sponsor ID: HIPPRECAU / 1512934414
Conditions: Osteoarthritis of Hip
Study type: Interventional
Recruitment status: Completed
Enrolment: 321 participants (actual)
Lead sponsor: West Virginia UniversityUniversity, hospital or other
Collaborators: University of Kentucky, Andrews Institute Orthopaedics & Sports Medicine
Study start: Apr 2016 (actual)
Primary completion: Apr 2019 (actual)
Study completion: Jun 2020 (actual)
First posted: 14 Nov 2017 (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.

Detailed description

Participants at the following institutions (West Virginia University; The Andrews Institute; and University of Kentucky Healthcare Sports Medicine will be given an educational session regarding hip replacement and procedures to follow after total hip replacement at their History and Physical visit prior to elective total hip replacement surgery via a posterior approach. 2. Participants will be told of the study after their educational session. All their questions will be answered and they will be given the opportunity to consent for participation. 3. After consent, the participant will be randomized to a control group receiving Standard of Care (education) hip precautions or to a 'no hip precautions' group. The control group will be instructed to practice postoperative hip precautions they learned at their educational session; (standard of care) (no flexion > 90 degrees, no internal rotation, no adduction) for 6 weeks. The intervention group will be aware of the precautions but will be told not to practice them post-operatively. 4. The participants will be monitored per the surgeons' normal routine post-operatively, which includes notification to the surgeon if the subject returns to the hospital with any hip problems. 5. After the first three participants who were randomized to 'no precautions' have returned for their post-op visit at all sites, the DSMB will have a teleconference to discuss any adverse events including dislocations. If any of the first 3 participants dislocated the study will be stopped. 6. At six weeks the following will be recorded: time to elimination of walking aids, dislocation episodes requiring closed reduction, and need for revision surgery. If any of the first 3 intervention participants dislocated during the 6 week period, the study will be stopped. 7. The participants will be asked to complete the HOOS Jr. and VAS follow-up questions at 2-week, 6-week, 3 month, 6 month and one year post-operatively per standard of care follow-up. Participants will be asked to list any hip precautions practiced at these time frames. 8. If the participants fail to come for the standard of care follow up appointments, the research assistant will call the participants and ask the HOOS Jr. and VAS questionnaires over the phone and to list any hip precautions they practiced.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No hip precautions	Experimental	Procedure: No hip precautionsNo hip precautions practiced after THA surgery
Hip precautions	No intervention	–Hip precautions practiced per standard of care after THA surgery

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

scheduled for elective, primary, osteoarthritic total hip arthroplasty via a posterolateral approach

Key exclusion criteria (1 listed)

< 18 years of age, cognitive disorders, neuromuscular spasticity disorders, femoral neck fractures, connective tissue disorders (ie Ehlers Danlos), alcohol abuse, dual mobility implant, constrained implants, pregnant or planning to become pregnant at time of consent.

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
No hip precautionsNo hip precautions practiced after THA surgery	Procedure or surgery	No hip precautions

Primary outcome

Dislocation Rate
Time frame: up to 1 year post op
Occurrence of dislocations will be compared between groups.

4 secondary outcomes

HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)
Time frame: up to 1 year post op
Visual Analog Scale (VAS)
Time frame: up to 1 year post op
Time free from walking aid
Time frame: up to 1 year post op
Hip Precautions Practiced
Time frame: up to 6 week post-op

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 7 Aug 2020.
BackgroundAustrailian Orthopaedic Association National Joint Replacement Registry., Annual Report. 2012
Background: PubMed 19577890Hummel MT, Malkani AL, Yakkanti MR, Baker DL. Decreased dislocation after revision total hip arthroplasty using larger femoral head size and posterior capsular repair. J Arthroplasty. 2009 Sep;24(6 Suppl):73-6. doi: 10.1016/j.arth.2009.04.026. Epub 2009 Jul 4.
Background: PubMed 15469226Soong M, Rubash HE, Macaulay W. Dislocation after total hip arthroplasty. J Am Acad Orthop Surg. 2004 Sep-Oct;12(5):314-21. doi: 10.5435/00124635-200409000-00006.
Background: PubMed 15043109Suh KT, Park BG, Choi YJ. A posterior approach to primary total hip arthroplasty with soft tissue repair. Clin Orthop Relat Res. 2004 Jan;(418):162-7. doi: 10.1097/00003086-200401000-00026.
Background: PubMed 7217144Ali Khan MA, Brakenbury PH, Reynolds IS. Dislocation following total hip replacement. J Bone Joint Surg Br. 1981;63-B(2):214-8. doi: 10.1302/0301-620X.63B2.7217144.
Background: PubMed 16741469Khatod M, Barber T, Paxton E, Namba R, Fithian D. An analysis of the risk of hip dislocation with a contemporary total joint registry. Clin Orthop Relat Res. 2006 Jun;447:19-23. doi: 10.1097/01.blo.0000218752.22613.78.
Background: PubMed 9917607Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998 Oct;(355):224-8. doi: 10.1097/00003086-199810000-00023.
Background: PubMed 12533567Phillips CB, Barrett JA, Losina E, Mahomed NN, Lingard EA, Guadagnoli E, Baron JA, Harris WH, Poss R, Katz JN. Incidence rates of dislocation, pulmonary embolism, and deep infection during the first six months after elective total hip replacement. J Bone Joint Surg Am. 2003 Jan;85(1):20-6. doi: 10.2106/00004623-200301000-00004.
Background: PubMed 25556661Schmidt-Braekling T, Waldstein W, Akalin E, Benavente P, Frykberg B, Boettner F. Minimal invasive posterior total hip arthroplasty: are 6 weeks of hip precautions really necessary? Arch Orthop Trauma Surg. 2015 Feb;135(2):271-274. doi: 10.1007/s00402-014-2146-x. Epub 2015 Jan 4.
Background: PubMed 26328242Barnsley L, Barnsley L, Page R. Are Hip Precautions Necessary Post Total Hip Arthroplasty? A Systematic Review. Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):230-5. doi: 10.1177/2151458515584640.
Background: PubMed 21076896Restrepo C, Mortazavi SM, Brothers J, Parvizi J, Rothman RH. Hip dislocation: are hip precautions necessary in anterior approaches? Clin Orthop Relat Res. 2011 Feb;469(2):417-22. doi: 10.1007/s11999-010-1668-y.
Background: PubMed 23523485Barrett WP, Turner SE, Leopold JP. Prospective randomized study of direct anterior vs postero-lateral approach for total hip arthroplasty. J Arthroplasty. 2013 Oct;28(9):1634-8. doi: 10.1016/j.arth.2013.01.034. Epub 2013 Mar 19.
Individual participant dataSharing planned: No. Individual data will not be available. Group data will be published.

Related trials for Osteoarthritis of Hip

Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With 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.

Matthew J Dietz, MD principal investigator

West Virginia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing No hip precautions in people with Osteoarthritis of Hip, run by West Virginia University 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 1 inclusion and 1 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 7 Aug 2020. 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?

Dislocation Rate (time frame: up to 1 year post op). 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 NCT03341442, which also lists 13 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 7 Aug 2020.