Back to resultsPostoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial
Primary Purpose
Osteoarthritis, Degenerative Joint Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip Precautions
No Hip Precautions
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring total hip arthroplasty, hip precautions, posterior approach
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing a primary total hip arthroplasty via the posterior approach by participating attending surgeons at this institution
- Index diagnosis of noninflammatory arthritis
- Patients must be able to understand and comply with study procedures
Exclusion Criteria:
- Allergy or intolerance to the study materials
- History of previous surgeries on the affected joint other than arthroscopy; i.e. revision THA or open surgeries
Sites / Locations
- Rush University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
No Hip Precautions
Hip Precautions
Arm Description
Patients will not be prescribed hip precautions in the first 6 weeks after surgery. The hip precautions that will no longer be prescribed are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
Patients will receive the following hip precautions: no hip flexion past 90º, no crossing the legs, and no twisting at the waist for the first six weeks after surgery.
Outcomes
Primary Outcome Measures
Dislocation
Incidence of dislocation of the total hip arthroplasty will be recorded for both treatment groups.
Secondary Outcome Measures
Activities of Daily Living
The time from surgery to return to activities of daily living will be measured for both treatment groups. This includes return to activities of bathing, return to work, and return to driving.
Full Information
NCT ID
NCT02686528
First Posted
January 11, 2016
Last Updated
October 25, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02686528
Brief Title
Postoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial
Official Title
Are Postoperative Hip Precautions Necessary After a Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if hip precautions, which are instructions that limit functional use of a hip replacement after surgery, affect the rate of dislocation in the first six weeks after primary total hip replacement surgery. The impact of hip precautions on a patient's return to activities of daily living and overall patient satisfaction will also be investigated. The overall cost effectiveness of hip precautions will be determined.
Detailed Description
This study examines the necessity of postoperative hip precautions in patients after primary total hip arthroplasty via the posterior approach. Precautions are instructions that limit the functional use of the hip and are given for the first six weeks after surgery, with the goal of preventing an instability event resulting in dislocation. The hip precautions that will be investigated in this study are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Degenerative Joint Disease
Keywords
total hip arthroplasty, hip precautions, posterior approach
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No Hip Precautions
Arm Type
Experimental
Arm Description
Patients will not be prescribed hip precautions in the first 6 weeks after surgery. The hip precautions that will no longer be prescribed are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
Arm Title
Hip Precautions
Arm Type
Active Comparator
Arm Description
Patients will receive the following hip precautions: no hip flexion past 90º, no crossing the legs, and no twisting at the waist for the first six weeks after surgery.
Intervention Type
Other
Intervention Name(s)
Hip Precautions
Intervention Description
Hip precautions are functional limitations of the hip replacement prescribed to patients for the first six weeks after surgery and are no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
Intervention Type
Other
Intervention Name(s)
No Hip Precautions
Intervention Description
Patients will not be prescribed hip precautions in the first 6 weeks after surgery. The hip precautions that will no longer be prescribed are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
Primary Outcome Measure Information:
Title
Dislocation
Description
Incidence of dislocation of the total hip arthroplasty will be recorded for both treatment groups.
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
Activities of Daily Living
Description
The time from surgery to return to activities of daily living will be measured for both treatment groups. This includes return to activities of bathing, return to work, and return to driving.
Time Frame
1 year after surgery
Other Pre-specified Outcome Measures:
Title
Use of Assistive Devices After Surgery
Description
Patients will be surveyed in clinic after surgery about their use of assistive devices including seat extenders, extra pillows between the legs, and walkers. The use of these devices between groups will be compared and the cost per patient in each group for use of these devices will be determined, allowing for analysis of potential cost savings for patients not prescribed hip precautions.
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing a primary total hip arthroplasty via the posterior approach by participating attending surgeons at this institution
Index diagnosis of noninflammatory arthritis
Patients must be able to understand and comply with study procedures
Exclusion Criteria:
Allergy or intolerance to the study materials
History of previous surgeries on the affected joint other than arthroscopy; i.e. revision THA or open surgeries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tori A Edmiston, MD
Phone
708-236-2664
Email
levine.research@rushortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Levine, MD, MS
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial
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