A Study of Posterior Hip Precautions After Total Hip Arthroplasty (HIPPRECAU)
Primary Purpose
Osteoarthritis of Hip
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No hip precautions
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Hip
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.
Sites / Locations
- WVU Medicine Department of Orthopaedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
No hip precautions
Hip precautions
Arm Description
No hip precautions practiced after THA surgery
Hip precautions practiced per standard of care after THA surgery
Outcomes
Primary Outcome Measures
Dislocation Rate
Occurrence of dislocations will be compared between groups.
Secondary Outcome Measures
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
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
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
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.
Full Information
NCT ID
NCT03341442
First Posted
October 25, 2017
Last Updated
August 6, 2020
Sponsor
West Virginia University
Collaborators
University of Kentucky, Andrews Institute Orthopaedics & Sports Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03341442
Brief Title
A Study of Posterior Hip Precautions After Total Hip Arthroplasty
Acronym
HIPPRECAU
Official Title
Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
Collaborators
University of Kentucky, Andrews Institute Orthopaedics & Sports Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
321 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No hip precautions
Arm Type
Experimental
Arm Description
No hip precautions practiced after THA surgery
Arm Title
Hip precautions
Arm Type
No Intervention
Arm Description
Hip precautions practiced per standard of care after THA surgery
Intervention Type
Procedure
Intervention Name(s)
No hip precautions
Intervention Description
No hip precautions practiced after THA surgery
Primary Outcome Measure Information:
Title
Dislocation Rate
Description
Occurrence of dislocations will be compared between groups.
Time Frame
up to 1 year post op
Secondary Outcome Measure Information:
Title
HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)
Description
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
Time Frame
up to 1 year post op
Title
Visual Analog Scale (VAS)
Description
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
Time Frame
up to 1 year post op
Title
Time free from walking aid
Description
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
Time Frame
up to 1 year post op
Title
Hip Precautions Practiced
Description
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.
Time Frame
up to 6 week post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Dietz, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Medicine Department of Orthopaedics
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual data will not be available. Group data will be published.
Citations:
PubMed Identifier
14984361
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Citation
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A Study of Posterior Hip Precautions After Total Hip Arthroplasty
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