Postoperative Hip Precautions for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Omar Behery, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Disqualifiers: Allergy, Previous surgeries, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment 'Postoperative Hip Precautions for Osteoarthritis'?

Research suggests that hip precautions, which are movement restrictions after hip surgery, do not significantly impact early recovery or reduce dislocation rates in patients with osteoarthritis undergoing total hip replacement. In fact, some studies indicate that these precautions may not provide additional benefits and could potentially slow down recovery. ^{1 2 3 4 5}

Are hip precautions safe for humans after hip surgery?

Research suggests that hip precautions, which are movement restrictions after hip surgery, are generally safe for humans. However, they may not provide additional benefits in preventing dislocation and could potentially slow down recovery. ^{1 2 3 4 5}

How does the treatment of hip precautions differ from other treatments for osteoarthritis after hip replacement?

Hip precautions involve movement restrictions after hip replacement surgery to prevent dislocation, but recent studies suggest they may not be necessary and could hinder recovery. This approach is unique because it challenges the traditional practice of imposing movement limits, suggesting that some patients may recover just as well without these restrictions. ^{1 2 3 4 5}

Research Team

Omar Behery, MD

Principal Investigator

Orthopedics Surgeon

Eligibility Criteria

This trial is for patients with noninflammatory arthritis who are having their first total hip replacement through the posterior approach. They must understand and follow study procedures but can't join if they have allergies to materials used in the study or previous major surgeries on the affected joint.

Inclusion Criteria

Patients must be able to understand and comply with study procedures

I am having my first total hip replacement surgery through the back of the hip by a surgeon from this hospital.

My arthritis is not caused by inflammation.

Exclusion Criteria

I have had surgery on the affected joint, but only arthroscopy.

Allergy or intolerance to the study materials

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total hip arthroplasty and are assigned to either receive or not receive hip precautions for the first six weeks after surgery

6 weeks

Follow-up

Participants are monitored for dislocation, use of assistive devices, and return to activities of daily living

1 year

Treatment Details

Interventions

• Hip Precautions (Behavioural Intervention)
• No Hip Precautions (Behavioural Intervention)

Trial Overview The study is testing whether following 'hip precautions' after a hip replacement surgery affects dislocation rates, recovery of daily activities, patient satisfaction, and cost-effectiveness compared to not using these precautions.

Participant Groups

Group I: No Hip Precautions Experimental Treatment 1 Intervention

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.

Group II: Hip Precautions Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Dr. Omar B. Lateef

Rush University Medical Center

Chief Executive Officer since 2022

MD from Des Moines University, Fellowship in Pulmonary and Critical Care Medicine at Rush University Medical Center

Dr. Paul E. Casey

Rush University Medical Center

Chief Medical Officer since 2021

MD, MBA

Findings from Research

In a study involving 313 patients who underwent total hip arthroplasty, not using hip precautions post-surgery did not lead to better recovery outcomes compared to standard precautions, except for a lower HOOS Jr score at 2 weeks.

The rate of dislocations was similar between the two groups, with 1.3% in the standard hip precautions group and 0.7% in the no hip precautions group, indicating that eliminating precautions did not increase dislocation risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posterior Hip Precautions Do Not Impact Early Recovery in Total Hip Arthroplasty: A Multicenter, Randomized, Controlled Study. Dietz, MJ., Klein, AE., Lindsey, BA., et al.[2020]

Patients who received hip precautions after total hip replacement had mixed feelings; some found them restrictive while others felt reassured, indicating a psychological impact on recovery.

Those without hip precautions experienced less anxiety about dislocation but lacked guidance on safe rehabilitation, suggesting that while precautions may increase fear, clear instructions are essential for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip precautions after total hip replacement and their discontinuation from practice: patient perceptions and experiences. Lightfoot, CJ., Coole, C., Sehat, KR., et al.[2021]

In a study of 346 patients who underwent posterior total hip arthroplasty (THA), eliminating hip precautions did not increase the dislocation rate, with 0% dislocation in the no precaution group compared to 2.29% in the precaution group.

All dislocations occurred in the hip precaution group, and there were no significant differences in patient-reported outcomes at 2, 6, or 12 weeks, suggesting that hip precautions may not be necessary for patients achieving specific intraoperative stability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients Achieving 90°/45°/0° Intraoperative Stability Do Not Require Hip Precautions Following Posterior Approach Total Hip Arthroplasty: A Prospective Randomized Study. Mounts, MR., Turner, RA., Patel, NB., et al.[2022]

A systematic review of 9 studies involving 8,835 participants found no significant difference in the risk of early hip dislocations after total hip arthroplasty (THA) between patients who followed hip precautions and those who did not.

The evidence suggests that routinely prescribing hip precautions post-surgery may not be necessary, as they could slightly reduce functional performance without significantly preventing dislocations, indicating a need for higher-quality studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip precautions after posterior-approach total hip arthroplasty among patients with primary hip osteoarthritis do not influence early recovery: a systematic review and meta-analysis of randomized and non-randomized studies with 8,835 patients. Korfitsen, CB., Mikkelsen, LR., Mikkelsen, ML., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Posterior Hip Precautions Do Not Impact Early Recovery in Total Hip Arthroplasty: A Multicenter, Randomized, Controlled Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Hip precautions after total hip replacement and their discontinuation from practice: patient perceptions and experiences. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Hip precautions after primary total hip arthroplasty: a qualitative exploration of clinical reasoning. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patients Achieving 90°/45°/0° Intraoperative Stability Do Not Require Hip Precautions Following Posterior Approach Total Hip Arthroplasty: A Prospective Randomized Study. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Hip precautions after posterior-approach total hip arthroplasty among patients with primary hip osteoarthritis do not influence early recovery: a systematic review and meta-analysis of randomized and non-randomized studies with 8,835 patients. [2023]