Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03806114

Conditions

Arthroplasty, Hip Replacement

Arthroplasties, Hip Replacement

Health-Related Quality Of Life

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Posterior Approach Precautions

Anterior Approach Precautions

No Precautions

Study Details

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.

Conditions

Arthroplasty, Hip Replacement

Arthroplasties, Hip Replacement

Health-Related Quality Of Life

Study ID

NCT03806114

Start date

Jun 21, 2019

Status verified date

Aug, 2022

Completion date

Dec 21, 2023

Anticipated

Primary completion date

Jun 21, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

212 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Anterior Approach Precautions

This group receives precautions and have a total hip arthroplasty with a posterior approach.

other: Posterior Approach Precautions

This group receives precautions and have a total hip arthroplasty with a posterior approach.

other: Anterior Approach No Precautions

This group receives does not precautions and have a total hip arthroplasty with an anterior approach.

other: Posterior Approach No Precautions

This group receives does not receive precautions and have a total hip arthroplasty with a posterior approach.

Interventions

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.

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.

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.

Primary outcome measure

  • Change in Oxford Hip Score [ Time Frame: Week before surgery to 6 months after surgery ]

Central Contacts and Locations

Central contacts

Johanna Dobransky

613-737-8899jdobransky@ohri.ca

Meaghan Dufresne

613-737-8899meadufresne@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Johanna Dobransky

613-737-8899jdobransky@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Aug 8, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-08-08.