NCT03341442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

October 25, 2017

Last Update Submit

August 6, 2020

Conditions

Osteoarthritis of Hip

Outcome Measures

Primary Outcomes (1)

  • Dislocation Rate

    Occurrence of dislocations will be compared between groups.

    up to 1 year post op

Secondary Outcomes (4)

  • HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)

    up to 1 year post op

  • Visual Analog Scale (VAS)

    up to 1 year post op

  • Time free from walking aid

    up to 1 year post op

  • Hip Precautions Practiced

    up to 6 week post-op

Study Arms (2)

No hip precautions

EXPERIMENTAL

No hip precautions practiced after THA surgery

Procedure: No hip precautions

Hip precautions

NO INTERVENTION

Hip precautions practiced per standard of care after THA surgery

Interventions

No hip precautionsPROCEDURE

No hip precautions practiced after THA surgery

No hip precautions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

Location

Related Publications (13)

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

    BACKGROUND

  • 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.

    PMID: 19577890BACKGROUND

  • 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.

    PMID: 15469226BACKGROUND

  • 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.

    PMID: 15043109BACKGROUND

  • 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.

    PMID: 7217144BACKGROUND

  • 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.

    PMID: 16741469BACKGROUND

  • 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.

    PMID: 9917607BACKGROUND

  • 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.

    PMID: 12533567BACKGROUND

  • 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.

    PMID: 25556661BACKGROUND

  • 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.

    PMID: 26328242BACKGROUND

  • 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.

    PMID: 21076896BACKGROUND

  • 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.

    PMID: 23523485BACKGROUND

  • 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.

    PMID: 26620966BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Matthew J Dietz, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 14, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2019

Study Completion

June 1, 2020

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Individual data will not be available. Group data will be published.

Locations

US(1)