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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04070430
Other study ID # 19-01106
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date May 1, 2021

Study information

Verified date July 2021
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 1, 2021
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
2 weeks of partial weight bearing on crutches
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.
4 weeks of partial weight bearing on crutches
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.

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patient-reported-outcome (PRO) survey 6 weeks, 6 months, 12 months, and 24 months post-operatively.
Primary Change in modified Harris hip score (mHHS) 6 weeks, 6 months, 12 months, and 24 months post-operatively.
Primary Change in Non arthritic hip score (NAHS) 6 weeks, 6 months, 12 months, and 24 months post-operatively
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