Modifications of Devices for Hip Arthroscopy

Not Applicable

• Conditions: Hip Arthroscopy
• Interventions: Device: Modified hip capsule side fixed slotted cannula; Device: Modified bone graft delivery tool set

• Registration Number: NCT04516109
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2020-07-08
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-18
• Study Start: 2020-08-24
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 111

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arthroscopic bone grafting	Modified hip capsule side fixed slotted cannula	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.
Arthroscopic bone grafting	Modified bone graft delivery tool set	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.
Arthrosocpic labral repair	Modified hip capsule side fixed slotted cannula	Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.

Primary Outcome Measures

Name	Time	Method
Surgical time per technical phase measured in minutes	1 Day	* 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).

Secondary Outcome Measures

Name	Time	Method
Patient Outcomes: Change in Pain	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24	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.
Rate of Surgical Complications	Up to 24 months	Total number of complications determined to be related to the hip arthroscopy procedure.
Surgical costs per device used	1 Day	Cost to use each device in surgery, measured in US dollars.
Patient Outcomes: Post-operative Pain	Post operative up to Day 9	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.
Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24	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.
Patient Outcomes: Change in Non-Arthritic Hip Scores	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24	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.

Trial Locations

Locations (2)

UCHealth Steadman Hawkins Clinic - Denver; 🇺🇸 Englewood, Colorado, United States

University of Colorado, Hip Preservation Center, Orthopedic Department; 🇺🇸 Boulder, Colorado, United States