An interventional study of Modified hip capsule side fixed slotted cannula and Modified bone graft delivery tool set in Hip Arthroscopy, sponsored by University of Colorado, Denver. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.
Device: 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.
Device: Modified hip capsule side fixed slotted cannula · Device: Modified bone graft delivery tool set
Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.
Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.
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).
Time frame: 1 Day
Rate of Surgical Complications
Total number of complications determined to be related to the hip arthroscopy procedure.
Time frame: Up to 24 months
Surgical costs per device used
Cost to use each device in surgery, measured in US dollars.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Plan to share: No
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University of Colorado, Denver