A Study of Posterior Hip Precautions After Total Hip Arthroplasty

NCT ID: NCT03341442

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-06-30

Brief Summary

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.

Detailed Description

1. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No hip precautions

No hip precautions practiced after THA surgery

Group Type: EXPERIMENTAL

No hip precautions

Intervention Type: PROCEDURE

No hip precautions practiced after THA surgery

Hip precautions

Hip precautions practiced per standard of care after THA surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

No hip precautions

No hip precautions practiced after THA surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• < 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Kentucky

OTHER

Sponsor Role: collaborator

Andrews Institute Orthopaedics & Sports Medicine

UNKNOWN

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Dietz, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J Dietz, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, United States

Countries

United States

References

Austrailian Orthopaedic Association National Joint Replacement Registry., Annual Report. 2012

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19577890 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15469226 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15043109 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7217144 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 16741469 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 9917607 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 12533567 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25556661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26328242 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21076896 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23523485 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26620966 (View on PubMed)

Other Identifiers

1512934414

Identifier Type: -

Identifier Source: org_study_id