Hip FracturesNCT04070430
Crutch Use After Arthroscopic Hip Surgery
A study testing 2 weeks of partial weight bearing on crutches and 4 weeks of partial weight bearing on crutches in people with Hip Fractures and Hip Injuries, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Fractures, Hip Injuries
- What is being tested?
- 2 weeks of partial weight bearing on crutches and 4 weeks of partial weight bearing on crutches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hip arthroscopic surgery
Who cannot join
- Any surgery other than hip arthroscopy
- Age: less than 18 years of age
- Age: greater than 64 years of age
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hip Fractures, Hip Injuries
- Being tested
- 2 weeks of partial weight bearing on crutches, 4 weeks of partial weight bearing on crutches
- Keywords
- Arthroscopic hip surgery
- Medical subject headings
- Hip Fractures, Hip Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 weeks of partial weight bearing on crutchesOther
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 crutchesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: 4 weeks of partial weight bearing on crutches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient-reported-outcome (PRO) survey
Measured: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
Change in modified Harris hip score (mHHS)
Measured: 6 weeks, 6 months, 12 months, and 24 months post-operatively.
Change in Non arthritic hip score (NAHS)
Measured: 6 weeks, 6 months, 12 months, and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Youm, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070430
- Sponsor's protocol ID
- 19-01106
- Status last verified
- Jul 2021
- First submitted
- 26 Aug 2019
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 41637607
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crutch Use After Arthroscopic Hip Surgery
- ClinicalTrials.gov ID
- NCT04070430
- Acronym / sponsor ID
- 19-01106
- Conditions
- Hip Fractures, Hip Injuries
- Keywords
- Arthroscopic hip surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 weeks of partial weight bearing on crutches | Active comparator | Other: 2 weeks of partial weight bearing on crutchespost-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively |
| 4 weeks of partial weight bearing on crutches | Active comparator | Other: 4 weeks of partial weight bearing on crutchespost-operative patient reported outcome (PRO) scores will be collected 6 weeks, 6 months, 12 months, and 24 months post-operatively |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hip arthroscopic surgery
Key exclusion criteria (4 listed)
- Any surgery other than hip arthroscopy
- Age: less than 18 years of age
- Age: greater than 64 years of age
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 weeks of partial weight bearing on crutchesFollowing 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. | Other | 2 weeks of partial weight bearing on crutches |
| 4 weeks of partial weight bearing on crutchesFollowing 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. | Other | 4 weeks of partial weight bearing on crutches |
Primary outcome
Change in patient-reported-outcome (PRO) survey
Time frame: 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.
Change in Non arthritic hip score (NAHS)
Time frame: 6 weeks, 6 months, 12 months, and 24 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 41637607Shankar 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Youm, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 weeks of partial weight bearing on crutches and 4 weeks of partial weight bearing on crutches in people with Hip Fractures and Hip Injuries, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported-outcome (PRO) survey (time frame: 6 weeks, 6 months, 12 months, and 24 months post-operatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04070430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.