Clinical trial NCT04516109: Modifications of Devices for Hip Arthroscopy
Official title: Modifications of Devices for Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hip Arthroscopy
Keywords: Hip arthroscopy
Arthroscopy
Labral repair
bone grafting
Total hip arthroplasty
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All eligible patients undergoing hip arthroscopy by the principal investigator will be assigned to one of two groups for analysis, based on the appropriate SOC surgical treatment for FAI, hip dysplasia, or a combination of the two. All patients will undergo hip arthoscopy with the use of the modified hip capsule slotted cannula.
Primary purpose: TREATMENT

Brief summary: This is protocol is intended to demonstrate the principal investigator's improvements and modifications of a hip capsule side fixed slotted cannula for continued access to the hip joint and a bone graft delivery tool set for grafting subchrondral cysts during hip arthroscopy procedure.

Detailed description: Femoroacetabular impingement (FAI) and acetabular dysplasia represent the two most common causes of secondary osteoarthritis of the hip1-3 and the two main indications for Hip Preservation procedures. Most patients with these pathologies will undergo Hip Arthroscopy, either alone, or combined with bony realignment procedures. Hip arthroscopy has grown exponentially over the past 15 years and is currently being leveraged in the diagnosis and treatment of a wide range of hip joint problems.

In an effort to improve surgical techniques, make surgeries faster and reproducible, mitigate complications and increase patient safety, surgeons modify and improve commercially available and commonly used non-significant risk devices with the above goals in mind.

For these reasons, the Principal Investigator (PI) modified and improved two devices for hip arthroscopy. These include the modified (1) hip capsule side fixed slotted cannula for continued access to the hip joint and (2) bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure. After utilizing these modified devices clinically, the PI has been impressed with their impact and thus aims to demonstrate that the modifications provide significant improvements in surgical flow and technique, minimize surgical time (per technical phase), minimize surgical costs, result in an absolute low incidence of surgical complications, and ultimately improve patient outcomes.

Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 60 years diagnosed with FAI, Hip Dysplasia or the combination of the two.
* Persistent hip pain accompanied by mechanical symptoms refractory to nonoperative management lasting at least 3 months.
* Reproducible clinical examination findings suggestive of impingement and/or decreased range of motion, and positive radiographic findings on radiography, computed tomography with 3-dimensional reconstruction, and magnetic resonance imaging.
* Joint-space width \> 3 mm on all views of plain radiography and 3-dimensional computed tomography.
* Patients undergoing hip arthroscopy for the treatment of FAI, Hip Dysplasia, or the combination of the two by the Principal Invesitgator.

Exclusion Criteria:

* Age \<18 years.
* Prisoners.
* Pregnant women.
* Decisionally challenged.
* Does not speak or understand English.

Primary outcomes:
measure: Surgical time per technical phase measured in minutes
timeFrame: 1 Day
Secondary outcomes:
measure: Rate of Surgical Complications
timeFrame: Up to 24 months
measure: Surgical costs per device used
timeFrame: 1 Day
measure: Patient Outcomes: Post-operative Pain
timeFrame: Post operative up to Day 9
measure: Patient Outcomes: Change in Pain
timeFrame: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
measure: Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores
timeFrame: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
measure: Patient Outcomes: Change in Non-Arthritic Hip Scores
timeFrame: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Other outcomes:
Locations:
city: Boulder
country: United States
facility: University of Colorado, Hip Preservation Center, Orthopedic Department
state: Colorado
city: Englewood
country: United States
facility: UCHealth Steadman Hawkins Clinic - Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Omer Mei-Dan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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