A Study of Posterior Hip Precautions After Total Hip Arthroplasty
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | April 2016 |
| End Date: | April 2020 |
| Contact: | Matthew J Dietz, MD |
| Email: | mdietz@hsc.wvu.edu |
| Phone: | 304-293-3491 |
Are Posterior Hip Precautions Necessary? A Randomized, Controlled Study of Posterior Hip Precautions After Total Hip Arthroplasty
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.
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.
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.
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.
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.
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