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Dislocation Precautions

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03806114
Collaborator
(none)
212
Enrollment
1
Location
4
Arms
54
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Posterior Approach Precautions
  • Procedure: Anterior Approach Precautions
  • Procedure: No Precautions
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Impact of Dislocation Precautions on Fear and Function in Patients Undergoing Hip Replacement
Actual Study Start Date :
Jun 21, 2019
Anticipated Primary Completion Date :
Jun 21, 2023
Anticipated Study Completion Date :
Dec 21, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Oxford Hip Score [Week before surgery to 6 months after surgery]

    Assess function of the hip

Secondary Outcome Measures

  1. Change in Tampa Scale for Kinesiophobia [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.

  2. Change in Forgotten Joint Score [6 weeks after surgery to 6 months after surgery]

    This measures awareness of a replaced joint

  3. Change in EQ-5D-5L [Week before surgery to 6 months after surgery]

    This measures general health

  4. Canadian Patient Experience Survey - Inpatient Care (CPES-IC) [At 2 weeks after surgery]

    This will measure the patients' experience.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6

Sponsors and Collaborators

  • Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT03806114
Other Study ID Numbers:
  • 20180880
First Posted:
Jan 16, 2019
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 8, 2022