Modified hip capsule side fixed slotted cannula
DeviceModified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.
NCT Number: NCT04516109
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
University of Colorado, Hip Preservation Center, Orthopedic Department, Boulder, Colorado, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 Day
Time frame: Up to 24 months
Total number of complications determined to be related to the hip arthroscopy procedure.
Time frame: 1 Day
Cost to use each device in surgery, measured in US dollars.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
University of Colorado, Denver
Other
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