NCT02686528

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,133

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

9.6 years

First QC Date

January 11, 2016

Last Update Submit

November 13, 2025

Conditions

Keywords

total hip arthroplastyhip precautionsposterior approach

Outcome Measures

Primary Outcomes (1)

  • Dislocation

    Incidence of dislocation of the total hip arthroplasty will be recorded for both treatment groups.

    6 weeks after surgery

Secondary Outcomes (1)

  • Activities of Daily Living

    1 year after surgery

Other Outcomes (1)

  • Use of Assistive Devices After Surgery

    6 months after surgery

Study Arms (2)

No Hip Precautions

EXPERIMENTAL

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.

Other: No Hip Precautions

Hip Precautions

ACTIVE COMPARATOR

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.

Other: Hip Precautions

Interventions

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.

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.

No Hip Precautions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

OsteoarthritisJoint Diseases

Condition Hierarchy (Ancestors)

ArthritisMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Omar Behery, MD

    Orthopedics Surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Orthopaedic Surgery Adult Reconstruction and Replacement

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 19, 2016

Study Start

January 1, 2016

Primary Completion

July 21, 2025

Study Completion

November 1, 2025

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations