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A Study of Posterior Hip Precautions After Total Hip Arthroplasty

Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03341442
Acronym
HIPPRECAU
Enrollment
321
Registered
2017-11-14
Start date
2016-04-30
Completion date
2020-06-30
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of Hip

Brief summary

The purpose of this study is to perform a randomized controlled study to compare patients undergoing THA via a posterolateral approach to receive either standard of care post-surgery hip restrictions or to receive no restrictions. The investigators goal is to first complete a pilot study in which the investigators assess the short term dislocation rates 3-6 months and then continue to recruit into this study and follow these patients for a year to determine the 1 year risk for dislocation. The investigators also will compare the HOOS Jr. and VAS scores and time until free from walking aid. The research question is: Will the elimination of post operative posterior hip precautions increase the dislocation rate? The hypothesis is that the elimination of post operative hip precautions will not increase the dislocation rate.

Detailed description

1\. Participants at the following institutions (West Virginia University; The Andrews Institute; and University of Kentucky Healthcare Sports Medicine will be given an educational session regarding hip replacement and procedures to follow after total hip replacement at their History and Physical visit prior to elective total hip replacement surgery via a posterior approach. 2. Participants will be told of the study after their educational session. All their questions will be answered and they will be given the opportunity to consent for participation. 3. After consent, the participant will be randomized to a control group receiving Standard of Care (education) hip precautions or to a 'no hip precautions' group. The control group will be instructed to practice postoperative hip precautions they learned at their educational session; (standard of care) (no flexion \> 90 degrees, no internal rotation, no adduction) for 6 weeks. The intervention group will be aware of the precautions but will be told not to practice them post-operatively. 4. The participants will be monitored per the surgeons' normal routine post-operatively, which includes notification to the surgeon if the subject returns to the hospital with any hip problems. 5. After the first three participants who were randomized to 'no precautions' have returned for their post-op visit at all sites, the DSMB will have a teleconference to discuss any adverse events including dislocations. If any of the first 3 participants dislocated the study will be stopped. 6. At six weeks the following will be recorded: time to elimination of walking aids, dislocation episodes requiring closed reduction, and need for revision surgery. If any of the first 3 intervention participants dislocated during the 6 week period, the study will be stopped. 7. The participants will be asked to complete the HOOS Jr. and VAS follow-up questions at 2-week, 6-week, 3 month, 6 month and one year post-operatively per standard of care follow-up. Participants will be asked to list any hip precautions practiced at these time frames. 8. If the participants fail to come for the standard of care follow up appointments, the research assistant will call the participants and ask the HOOS Jr. and VAS questionnaires over the phone and to list any hip precautions they practiced.

Interventions

No hip precautions practiced after THA surgery

Sponsors

University of Kentucky
CollaboratorOTHER
Andrews Institute Orthopaedics & Sports Medicine
CollaboratorUNKNOWN
West Virginia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* scheduled for elective, primary, osteoarthritic total hip arthroplasty via a posterolateral approach

Exclusion criteria

* \< 18 years of age, cognitive disorders, neuromuscular spasticity disorders, femoral neck fractures, connective tissue disorders (ie Ehlers Danlos), alcohol abuse, dual mobility implant, constrained implants, pregnant or planning to become pregnant at time of consent.

Design outcomes

Primary

MeasureTime frameDescription
Dislocation Rateup to 1 year post opOccurrence of dislocations will be compared between groups.

Secondary

MeasureTime frameDescription
HOOS, JR (hip disability and osteoarthritis outcome score for joint replacement)up to 1 year post opChange in baseline score over time will be compared between groups. This is a six question form asked at Pre-op, 2 week, 6 week, 3-6 month, and 1 year post op
Visual Analog Scale (VAS)up to 1 year post opChange in baseline Visual Analog Scale (VAS) over time will be compared between groups. This scale is from 0-100, where 100 is the best, evaluating the patients Health State and will be given at Pre-op, 2 week, 6 week, 3-6 month, and 1 year post op
Time free from walking aidup to 1 year post opTime taken to be free from walking aids will be used to identify differences between groups. This will be evaluated by the provider at 6 weeks, 3/6 months, and 1 year post op
Hip Precautions Practicedup to 6 week post-opHip precautions practiced per patient postoperatively will be compared between groups to identify change in dislocation rates. Patients will be asked at 2 & 6 week post op what if any precautions they practiced.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026