Modifications of Devices for Hip Arthroscopy

February 6, 2023 updated by: University of Colorado, Denver
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Boulder, Colorado, United States, 80304
        • University of Colorado, Hip Preservation Center, Orthopedic Department
      • Englewood, Colorado, United States, 80112
        • UCHealth Steadman Hawkins Clinic - Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time per technical phase measured in minutes
Time Frame: 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).
1 Day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 24, 2020

Primary Completion (ANTICIPATED)

August 1, 2024

Study Completion (ANTICIPATED)

August 1, 2026

Study Registration Dates

First Submitted

July 8, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-2755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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