NCT04070430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

August 26, 2019

Last Update Submit

July 28, 2021

Conditions

Keywords

Arthroscopic hip surgery

Outcome Measures

Primary Outcomes (3)

  • Change in patient-reported-outcome (PRO) survey

    6 weeks, 6 months, 12 months, and 24 months post-operatively.

  • Change in modified Harris hip score (mHHS)

    6 weeks, 6 months, 12 months, and 24 months post-operatively.

  • Change in Non arthritic hip score (NAHS)

    6 weeks, 6 months, 12 months, and 24 months post-operatively

Study Arms (2)

2 weeks of partial weight bearing on crutches

ACTIVE COMPARATOR

post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively

Other: 2 weeks of partial weight bearing on crutches

4 weeks of partial weight bearing on crutches

ACTIVE COMPARATOR

post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively

Other: 4 weeks of partial weight bearing on crutches

Interventions

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.

2 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.

4 weeks of partial weight bearing on crutches

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hip arthroscopic surgery

You may not qualify if:

  • Any surgery other than hip arthroscopy
  • Age: less than 18 years of age
  • Age: greater than 64 years of age
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

  • Shankar DS, Mojica ES, Blaeser AM, Vasavada KD, Bi AS, Youm T. Crutch use for 4 weeks vs. 1 week after hip arthroscopy for femoroacetabular impingement: A pseudorandomized clinical trial with 6-month follow-up. Bull Hosp Jt Dis (2013). 2025 Dec 1;83(1):129-134. doi: 10.1097/bh9.0000000000000020. Epub 2025 Dec 3.

MeSH Terms

Conditions

Hip FracturesHip Injuries

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesLeg Injuries

Study Officials

  • Thomas Youm, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

September 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL, SAP
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.

Locations