Back to resultsCrutch Use After Arthroscopic Hip Surgery
Primary Purpose
Hip Fractures, Hip Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 weeks of partial weight bearing on crutches
4 weeks of partial weight bearing on crutches
Sponsored by
About this trial
This is an interventional other trial for Hip Fractures focused on measuring Arthroscopic hip surgery
Eligibility Criteria
Inclusion Criteria:
- Hip arthroscopic surgery
Exclusion Criteria:
- Any surgery other than hip arthroscopy
- Age: less than 18 years of age
- Age: greater than 64 years of age
- Pregnant patients
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2 weeks of partial weight bearing on crutches
4 weeks of partial weight bearing on crutches
Arm Description
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
Outcomes
Primary Outcome Measures
Change in patient-reported-outcome (PRO) survey
Change in modified Harris hip score (mHHS)
Change in Non arthritic hip score (NAHS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04070430
Brief Title
Crutch Use After Arthroscopic Hip Surgery
Official Title
Crutch Use After Arthroscopic Hip Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether crutch use for 4 weeks following hip arthroscopic surgery is superior to crutch use for 2 weeks following hip arthroscopic surgery. The primary objective of the study is to compare PRO scores between patients who have used crutches for 2 weeks and patients who have used crutches for 4 weeks.
Detailed Description
This will be a single-center, randomized prospective study. The study will compare post-operative patient reported outcome (PRO) scores including the modified Harris hip score (mHHS) and the non arthritic hip score (NAHS), both are externally-validated surveys for hip function. One cohort will be assigned a rehabilitation regimen that includes 2 weeks of partial weight bearing on crutches, and the other will be assigned a regimen of 4 weeks of partial weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Hip Injuries
Keywords
Arthroscopic hip surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 weeks of partial weight bearing on crutches
Arm Type
Active Comparator
Arm Description
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
Arm Title
4 weeks of partial weight bearing on crutches
Arm Type
Active Comparator
Arm Description
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
Intervention Type
Other
Intervention Name(s)
2 weeks of partial weight bearing on crutches
Intervention Description
Following surgery, patients will be instructed by their surgeon to use crutches for 2 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.
Intervention Type
Other
Intervention Name(s)
4 weeks of partial weight bearing on crutches
Intervention Description
Following surgery, patients will be instructed by their surgeon to use crutches for 4 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.
Primary Outcome Measure Information:
Title
Change in patient-reported-outcome (PRO) survey
Time Frame
6 weeks, 6 months, 12 months, and 24 months post-operatively.
Title
Change in modified Harris hip score (mHHS)
Time Frame
6 weeks, 6 months, 12 months, and 24 months post-operatively.
Title
Change in Non arthritic hip score (NAHS)
Time Frame
6 weeks, 6 months, 12 months, and 24 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hip arthroscopic surgery
Exclusion Criteria:
Any surgery other than hip arthroscopy
Age: less than 18 years of age
Age: greater than 64 years of age
Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Youm, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Learn more about this trial
Crutch Use After Arthroscopic Hip Surgery
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