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Device

Modified Arthroscopy Tools for Hip Surgery

N/A
Waitlist Available
Led By Omer Mei-Dan, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persistent hip pain accompanied by mechanical symptoms refractory to nonoperative management lasting at least 3 months.
Males or females between the ages of 18 and 60 years diagnosed with FAI, Hip Dysplasia or the combination of the two
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, week 6, month 3, month 6, month 12, month 24
Awards & highlights

Study Summary

This trial is testing a new tool for delivering bone grafts during hip arthroscopy, in order to improve the procedure.

Who is the study for?
This trial is for adults aged 18-60 with persistent hip pain and mechanical symptoms that haven't improved with non-surgical treatments. They should have specific signs of impingement or limited motion, confirmed by imaging tests, and sufficient joint space. It's not open to minors, prisoners, pregnant women, those who are decisionally challenged or don't understand English.Check my eligibility
What is being tested?
The study is testing modified surgical tools in hip arthroscopy: a slotted cannula designed for better access to the hip joint and a tool set for delivering bone grafts to treat cysts. The goal is to see if these new tools improve the procedure.See study design
What are the potential side effects?
While the trial description doesn’t specify side effects related to the devices themselves, typical risks of hip arthroscopy may include infection, bleeding, nerve injury or reactions from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had hip pain for over 3 months that hasn't improved with non-surgical treatments.
Select...
I am between 18 and 60 years old with a diagnosis of FAI, Hip Dysplasia, or both.
Select...
My joint space is wider than 3 mm on all X-ray and CT scan images.
Select...
I have joint pain, limited movement, and my scans show joint issues.
Select...
I have had hip pain for over 3 months that hasn't improved with non-surgical treatments.
Select...
I am having hip surgery for FAI, Hip Dysplasia, or both.
Select...
My joint-space width is over 3 mm on all X-ray and CT scan views.
Select...
I am having hip surgery for FAI, Hip Dysplasia, or both by the study's lead researcher.
Select...
I am between 18 and 60 years old with a diagnosis of FAI, Hip Dysplasia, or both.
Select...
I have signs of impingement, limited movement, and positive imaging tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, week 6, month 3, month 6, month 12, month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, week 6, month 3, month 6, month 12, month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Surgical time per technical phase measured in minutes
Secondary outcome measures
Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores
Patient Outcomes: Change in Non-Arthritic Hip Scores
Patient Outcomes: Change in Pain
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Arthroscopic bone graftingActive Control2 Interventions
Patients undergoing arthroscopic bone grafting of subchrondral cyst with the use of the modified bone graft delivery tool set and modified hip capsule slotted cannula.
Group II: Arthrosocpic labral repairActive Control1 Intervention
Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,565 Total Patients Enrolled
Omer Mei-Dan, MDPrincipal InvestigatorUniversity of Colorado, Denver
3 Previous Clinical Trials
101 Total Patients Enrolled

Media Library

Modified bone graft delivery tool set (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04516109 — N/A
Hip Arthroscopy Research Study Groups: Arthroscopic bone grafting, Arthrosocpic labral repair
Hip Arthroscopy Clinical Trial 2023: Modified bone graft delivery tool set Highlights & Side Effects. Trial Name: NCT04516109 — N/A
Modified bone graft delivery tool set (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516109 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my participation eligible for this research initiative?

"To be eligible for this clinical trial, potential patients should have undergone arthroscopy and lie between 18 to 60 years of age. A maximum of 111 people can take part in the experiment."

Answered by AI

Does this trial include minors as potential participants?

"Participants in this trial must be aged 18 years or above, yet not exceed the age of 60."

Answered by AI

Is there an opportunity to get involved in this investigation presently?

"According to the clinicaltrials.gov web page, this medical study is not presently welcoming new participants. It was initially published on August 24th 2020 and modified as recently as July 26th 2021. Although it is now closed for recruitment, there are 6 other trials actively searching for volunteers at present."

Answered by AI
~9 spots leftby Aug 2024