Modifications of Devices for Hip Arthroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modifications of Devices for Hip Arthroscopy

Conditions
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Hip Arthroscopy

Intervention / Treatment
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* Device: Modified hip capsule side fixed slotted cannula
* Device: Modified bone graft delivery tool set


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthrosocpic labral repair<br>Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula. | Device: Modified hip capsule side fixed slotted cannula<br>* Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.<br>|
| Active Comparator: Arthroscopic bone grafting<br>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. | Device: Modified hip capsule side fixed slotted cannula<br>* Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.<br>Device: Modified bone graft delivery tool set<br>* Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time per technical phase measured in minutes | We aim to demonstrate that the use of the modified device for hip arthroscopy is fast and efficient as measured by surgical time per technical phase (i.e. arthroscopic labral repair phase and arthroscopic bone grafting phase). Arthroscopic Labral Repair Phase: During hip arthoscopy, the surgical time of the arthroscopic labral repair phase will be collected. Arthroscopic Bone Grafting Phase: During hip arthoscopy, the surgical time of the bone grafting of the hip joint phase will be collected. In this design, the technical phase recorded will either be: 1) duration of arthroscopic labral repair phase (in patients only undergoing arthroscopic labral repair) or 2) duration of arthroscopic bone grafting phase (in patients undergoing arthroscopic bone grafting). | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Surgical Complications | Total number of complications determined to be related to the hip arthroscopy procedure. | Up to 24 months | 
| Surgical costs per device used | Cost to use each device in surgery, measured in US dollars. | 1 Day | 
| Patient Outcomes: Post-operative Pain | Pain, as assessed via a visual analog scale. Possible scores range from 0-100, with 0 indicating no pain and 100 indicating the most severe pain and a worse outcome. | Post operative up to Day 9 | 
| Patient Outcomes: Change in Pain | Pain, as assessed via a visual analog scale. Possible scores range from 0-100, with 0 indicating no pain and 100 indicating the most severe pain and a worse outcome. | Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24 | 
| Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores | The International Hip Outcome Tool (IHOT-12) measures both health-related quality of life and changes after treatment in young, active patients with hip disorders. Patients indicate their responses to the various questions by marking a 100 mm visual analog scale. The total score is calculated by calculating the mean of the participant's responses. Possible scores range from 0-100 with 0 indicating the worst and 100 indicating the best possible quality of life. | Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24 | 
| Patient Outcomes: Change in Non-Arthritic Hip Scores | The Non-Arthritic Hip score is a self-administered hip score measuring function and quality of life designed for use in younger patients with higher activity demands and treatment expectations than older patients with degenerative joint disease. Possible scores range from 0-4, with 0 indicating the worst and 4 indicating the best level of function and outcome for the patient. | Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip arthroscopy, Arthroscopy, Labral repair, bone grafting, Total hip arthroplasty