- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070430
Crutch Use After Arthroscopic Hip Surgery
July 28, 2021 updated by: NYU Langone Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2 weeks of partial weight bearing on crutches
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
|
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.
|
Active Comparator: 4 weeks of partial weight bearing on crutches
post-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in patient-reported-outcome (PRO) survey
Time Frame: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
|
6 weeks, 6 months, 12 months, and 24 months post-operatively.
|
Change in modified Harris hip score (mHHS)
Time Frame: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
|
6 weeks, 6 months, 12 months, and 24 months post-operatively.
|
Change in Non arthritic hip score (NAHS)
Time Frame: 6 weeks, 6 months, 12 months, and 24 months post-operatively
|
6 weeks, 6 months, 12 months, and 24 months post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Youm, MD, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
May 1, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
August 26, 2019
First Submitted That Met QC Criteria
August 26, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-01106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
Carilion ClinicCompleted
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
Clinical Trials on 2 weeks of partial weight bearing on crutches
-
Kahramanmaras Sutcu Imam UniversityCompletedFemur Intertrochanteric FracturesTurkey
-
Orthopaedic Associates of Michigan, PCGrand Rapids Medical Education PartnersCompleted
-
Rothman Institute OrthopaedicsUnknownPostoperative Pain | Hip ArthroplastyUnited States
-
BioCryst PharmaceuticalsApproved for marketingHereditary Angioedema | Prophylaxis | HAE
-
Umm Al-Qura UniversityCompletedDiabetic Peripheral NeuropathySaudi Arabia
-
Emory UniversitySanofiRecruitingAllergic Fungal RhinosinusitisUnited States
-
Eskisehir Osmangazi UniversityRecruiting
-
Marmara UniversityCompletedOsteochondral Lesion of TalusTurkey
-
Rabin Medical CenterTel Aviv University; The Leona M. and Harry B. Helmsley Charitable TrustRecruiting
-
Khon Kaen UniversityCompleted