Dislocation Precautions

August 5, 2022 updated by: Ottawa Hospital Research Institute

Impact of Dislocation Precautions on Fear and Function in Patients Undergoing Hip Replacement

This study is looking at the impact of giving patients precautions, or restrictions for movement, when undergoing a total hip replacement. Have of the participants will receive precautions, while the other half will not receive any precautions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing hip replacements are often told by health care providers to avoid specific positions and activities to decrease the risk of their hip dislocating following their surgery. This, however, results in patients becoming more fearful of moving and leads to limitations in their function and decreased quality of life. Previous research has shown that hip dislocations following surgery are most commonly attributed to poor implant position rather than the actions of the patients. Teaching precautions takes up healthcare resources and may use finances that are not necessarily required. This study aims to compare groups with half receiving precautions and half not receiving precautions, to assess the impact of precautions on the patients' quality of life.

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Receiving a primary total hip arthroplasty (THA) due to osteoarthritis or osteonecrosis
  • Over 18
  • Willing and able to sign consent

Exclusion Criteria:

  • Receiving a lateral approach hip arthroplasty
  • Cannot make follow up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Anterior Approach Precautions
This group receives precautions and have a total hip arthroplasty with a posterior approach.
Procedure: Anterior Approach Precautions
These patients will be advised to avoid extending the leg back, rotating the leg outwards, and lifting their bottom when lying down after their surgery for 6 weeks.
OTHER: Posterior Approach Precautions
This group receives precautions and have a total hip arthroplasty with a posterior approach.
Procedure: Posterior Approach Precautions
These patients will be advised not to bend their leg or trunk more than 90 degrees, avoid crossing the leg or crossing midline, and rotating the leg inwards. Patients will also be instructed to put a pillow in between their legs while sleeping for 6 weeks and to avoid bathing for 6 weeks.
OTHER: Anterior Approach No Precautions
This group receives does not precautions and have a total hip arthroplasty with an anterior approach.
Procedure: No Precautions
For the non-precautions group, there will be no mention of precautions by any providers before, during, and after surgery. No equipment will be given, but a list of self-care equipment will be available for 'comfort' purposes. Patients will be instructed to avoid bathing for 4 weeks. All groups will have instructions to use a walking aid and a toilet seat if needed, to weight-bear as tolerated, and to avoid driving for 3 weeks.
OTHER: Posterior Approach No Precautions
This group receives does not receive precautions and have a total hip arthroplasty with a posterior approach.
Procedure: No Precautions
For the non-precautions group, there will be no mention of precautions by any providers before, during, and after surgery. No equipment will be given, but a list of self-care equipment will be available for 'comfort' purposes. Patients will be instructed to avoid bathing for 4 weeks. All groups will have instructions to use a walking aid and a toilet seat if needed, to weight-bear as tolerated, and to avoid driving for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Hip Score
Time Frame: Week before surgery to 6 months after surgery
Assess function of the hip
Week before surgery to 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tampa Scale for Kinesiophobia
Time Frame: Week before surgery to 6 months after surgery
This assesses kinesiophobia, using a 17 item scale with each item using a 4 point Likert scale . The final score is the sum of all questions except for 4, 8, 12 and 16 which has their score inverted before being added. The final score ranges from from 17-68 points with 68 being the highest degree of kinesiophobia.
Week before surgery to 6 months after surgery
Change in Forgotten Joint Score
Time Frame: 6 weeks after surgery to 6 months after surgery
This measures awareness of a replaced joint
6 weeks after surgery to 6 months after surgery
Change in EQ-5D-5L
Time Frame: Week before surgery to 6 months after surgery
This measures general health
Week before surgery to 6 months after surgery
Canadian Patient Experience Survey - Inpatient Care (CPES-IC)
Time Frame: At 2 weeks after surgery
This will measure the patients' experience.
At 2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 21, 2019

Primary Completion (ANTICIPATED)

June 21, 2023

Study Completion (ANTICIPATED)

December 21, 2023

Study Registration Dates

First Submitted

January 14, 2019

First Submitted That Met QC Criteria

January 14, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 20180880

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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