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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02686528
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Rush University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Brett Levine, MD, MS
Principal Investigator Affiliation Assistant Professor
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Degenerative Joint Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Active Comparator: Hip Precautions

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.

Interventions

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.

Other: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rush University Medical Center, Chicago, Illinois

Status

Recruiting

Address

Rush University Medical Center

Chicago, Illinois, 60612

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