Postoperative Hip Precautions After Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial

Osteoarthritis Clinical Trial

Official title:

Are Postoperative Hip Precautions Necessary After a Total Hip Arthroplasty Via the Posterior Approach: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02686528
• Other study ID #: 13100906
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2025

Study information

• Verified date: November 2023
• Source: Rush University Medical Center
• Contact: Tori A Edmiston, MD
• Phone: 708-236-2664
• Email: levine.research[@]rushortho.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Other:
• Hip Precautions
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.
• No Hip Precautions
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.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of Assistive Devices After Surgery	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.	6 months after surgery
Primary	Dislocation	Incidence of dislocation of the total hip arthroplasty will be recorded for both treatment groups.	6 weeks after surgery
Secondary	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.	1 year after surgery