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Postoperative Hip Bracing After Hip Arthroscopy

Primary Purpose

Femoroacetabular Impingement Syndrome, Acetabular Labral Tear

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip brace
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoroacetabular Impingement Syndrome

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient age 14-60 on date of surgery
  • Patient seen at the institution for the study
  • Patient scheduled to undergo arthroscopic osteoplasty and labral repair for femoroacetabular impingement syndrome.

Exclusion Criteria:

  • Any patient anyone who cannot follow up in person in clinic for the 6-week postoperative visit.
  • Any patient with planned iliopsoas tendon release for tendonitis at the time of surgery, or who undergoes iliopsoas tendon release on the day of surgery (this may be a confounding variable as this is study looking at ability of the hip brace to prevent hip flexor tendonitis after surgery).
  • Non-English speaking patients (due to limited validation of the patient reported outcome measures in non-English speaking populations).

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Hip Brace

No Intervention

Arm Description

This group will be assigned to wear a hip brace post surgery.

This group will not be assigned a hip brace after surgery.

Outcomes

Primary Outcome Measures

patient numerical pain ranking scale (NPRS)
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.

Secondary Outcome Measures

HOOS - Hip disability and Osteoarthritis Outcome Score
questionnaire used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. Min 0, Max 100. Lower score means worse outcome.
VR12 - Veteran RAND 12 item health survey
general health outcome survey. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Patient using non-steroidal medication
yes / no
Patient received cortisone injection to hip flexor sheath or bursa
yes / no
Patient using opioid medication
yes / no
NPRS - numerical pain ranking scale
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.

Full Information

First Posted
October 6, 2020
Last Updated
October 31, 2022
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04599296
Brief Title
Postoperative Hip Bracing After Hip Arthroscopy
Official Title
A Randomized Controlled Pilot Trial of Postoperative Hip Bracing After Arthroscopic Osteoplasty and Labral Repair for Femoroacetabular Impingement Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement ("osteoplasty") and treatment of impingement-associated labral tears with labral repair. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The objective of this study is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.
Detailed Description
Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement ("osteoplasty") and treatment of impingement-associated labral tears with labral repair. The hip joint is subluxated with traction to accomplish this procedure. The diagnoses of FAIS and the incidence of hip arthroscopy have both increased dramatically in the last 20 years in the US -- in a recent study using IBM Marketscan to evaluate rates of hip arthroscopic treatment of FAIS, the investigators found this incidence doubled from 1.2 to 2.1 per 100,000 person-years in just a 3-year period. Despite the increasing incidence of hip arthroscopy in the US, on a recent review the investigators have found few evidence-based studies on postoperative care. A particular area of debate is the use of postoperative hip braces. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. They may also prevent overuse of the hip flexors by supporting the hip during gait. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The utility of bracing is important because hip braces are expensive (averaging $350-$600): if there are over 7000 hip arthroscopies performed nationwide and 50% of surgeons use hip braces, this amounts to over $2,000,000. The investigator's overall objective is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement Syndrome, Acetabular Labral Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients randomized to wearing a hip brace after surgery 36 Patients randomized to not wearing a hip brace after surgery 36
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The treating surgeon, who is also the PI, will be blind to randomization.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hip Brace
Arm Type
Active Comparator
Arm Description
This group will be assigned to wear a hip brace post surgery.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
This group will not be assigned a hip brace after surgery.
Intervention Type
Device
Intervention Name(s)
Hip brace
Intervention Description
Hip brace
Primary Outcome Measure Information:
Title
patient numerical pain ranking scale (NPRS)
Description
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Time Frame
6 weeks after surgery date
Secondary Outcome Measure Information:
Title
HOOS - Hip disability and Osteoarthritis Outcome Score
Description
questionnaire used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process. Min 0, Max 100. Lower score means worse outcome.
Time Frame
at 6 week and 6 month after surgery date
Title
VR12 - Veteran RAND 12 item health survey
Description
general health outcome survey. The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Time Frame
at 6 week and 6 month after surgery date
Title
Patient using non-steroidal medication
Description
yes / no
Time Frame
6 week and 6 month after surgery date
Title
Patient received cortisone injection to hip flexor sheath or bursa
Description
yes / no
Time Frame
6 week and 6 month after surgery date
Title
Patient using opioid medication
Description
yes / no
Time Frame
6 week and 6 month after surgery date
Title
NPRS - numerical pain ranking scale
Description
Validated pain scale, subject reported. Min 0, Max 10, Higher score means worse outcome.
Time Frame
3 weeks and 6 months after surgery date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age 14-60 on date of surgery Patient seen at the institution for the study Patient scheduled to undergo arthroscopic osteoplasty and labral repair for femoroacetabular impingement syndrome. Exclusion Criteria: Any patient anyone who cannot follow up in person in clinic for the 6-week postoperative visit. Any patient with planned iliopsoas tendon release for tendonitis at the time of surgery, or who undergoes iliopsoas tendon release on the day of surgery (this may be a confounding variable as this is study looking at ability of the hip brace to prevent hip flexor tendonitis after surgery). Non-English speaking patients (due to limited validation of the patient reported outcome measures in non-English speaking populations).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberlee E Moomey
Phone
206-520-8436
Email
kmoomey@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia Hagen, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mia Hagen
Phone
206-598-3404
Email
smia@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30647926
Citation
Adib F, Johnson AJ, Hennrikus WL, Nasreddine A, Kocher M, Yen YM. Iliopsoas tendonitis after hip arthroscopy: prevalence, risk factors and treatment algorithm. J Hip Preserv Surg. 2018 Dec 24;5(4):362-369. doi: 10.1093/jhps/hny049. eCollection 2018 Dec.
Results Reference
background
PubMed Identifier
26671201
Citation
Schairer WW, Nwachukwu BU, McCormick F, Lyman S, Mayman D. Use of Hip Arthroscopy and Risk of Conversion to Total Hip Arthroplasty: A Population-Based Analysis. Arthroscopy. 2016 Apr;32(4):587-93. doi: 10.1016/j.arthro.2015.10.002. Epub 2015 Dec 6.
Results Reference
background
PubMed Identifier
23916639
Citation
Bozic KJ, Chan V, Valone FH 3rd, Feeley BT, Vail TP. Trends in hip arthroscopy utilization in the United States. J Arthroplasty. 2013 Sep;28(8 Suppl):140-3. doi: 10.1016/j.arth.2013.02.039. Epub 2013 Aug 1.
Results Reference
background
PubMed Identifier
32604156
Citation
Yao JJ, Cook SB, Gee AO, Kweon CY, Hagen MS. What Is the Survivorship After Hip Arthroscopy for Femoroacetabular Impingement? A Large-database Study. Clin Orthop Relat Res. 2020 Oct;478(10):2266-2273. doi: 10.1097/CORR.0000000000001370.
Results Reference
background
PubMed Identifier
29028436
Citation
Shin JJ, McCrum CL, Mauro CS, Vyas D. Pain Management After Hip Arthroscopy: Systematic Review of Randomized Controlled Trials and Cohort Studies. Am J Sports Med. 2018 Nov;46(13):3288-3298. doi: 10.1177/0363546517734518. Epub 2017 Oct 13.
Results Reference
background
PubMed Identifier
21566069
Citation
Philippon MJ, Decker MJ, Giphart JE, Torry MR, Wahoff MS, LaPrade RF. Rehabilitation exercise progression for the gluteus medius muscle with consideration for iliopsoas tendinitis: an in vivo electromyography study. Am J Sports Med. 2011 Aug;39(8):1777-85. doi: 10.1177/0363546511406848. Epub 2011 May 12.
Results Reference
background
PubMed Identifier
27173983
Citation
Domb BG, Sgroi TA, VanDevender JC. Physical Therapy Protocol After Hip Arthroscopy: Clinical Guidelines Supported by 2-Year Outcomes. Sports Health. 2016 Jul;8(4):347-54. doi: 10.1177/1941738116647920. Epub 2016 May 12.
Results Reference
background
PubMed Identifier
25980403
Citation
Gupta A, Suarez-Ahedo C, Redmond JM, Gerhardt MB, Hanypsiak B, Stake CE, Finch NA, Domb BG. Best Practices During Hip Arthroscopy: Aggregate Recommendations of High-Volume Surgeons. Arthroscopy. 2015 Sep;31(9):1722-7. doi: 10.1016/j.arthro.2015.03.023. Epub 2015 May 14.
Results Reference
background
PubMed Identifier
28969949
Citation
Cvetanovich GL, Lizzio V, Meta F, Chan D, Zaltz I, Nho SJ, Makhni EC. Variability and Comprehensiveness of North American Online Available Physical Therapy Protocols Following Hip Arthroscopy for Femoroacetabular Impingement and Labral Repair. Arthroscopy. 2017 Nov;33(11):1998-2005. doi: 10.1016/j.arthro.2017.06.045. Epub 2017 Sep 29.
Results Reference
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PubMed Identifier
30467580
Citation
Bolia IK, Briggs KK, Matheny L, Philippon MJ. Survey results from an international hip course: comparison between experts and non-experts on hip arthroscopy clinical practice and post-operative rehabilitation. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1270-1275. doi: 10.1007/s00167-018-5289-4. Epub 2018 Nov 22.
Results Reference
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PubMed Identifier
28948037
Citation
Truntzer JN, Shapiro LM, Hoppe DJ, Abrams GD, Safran MR. Hip arthroscopy in the United States: an update following coding changes in 2011. J Hip Preserv Surg. 2017 Mar 23;4(3):250-257. doi: 10.1093/jhps/hnx004. eCollection 2017 Aug.
Results Reference
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Citation
Hagen M, Westermann R, Lynch T, Rosneck J. Rehabilitation for Femoroacetabular Impingement: Conservative Care and Postoperative Practice. J Hip Surg. 2018;02(04):189-193. doi:10.1055/s-0038-1676448
Results Reference
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Postoperative Hip Bracing After Hip Arthroscopy

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