Modifications of Devices for Hip Arthroscopy

NCT04516109 | Enrolling By Invitation

• 1 other identifier: 19-2755
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Arthroscopy

Keywords

Hip arthroscopy; Arthroscopy; Labral repair; bone grafting; Total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate of Surgical Complications

  Up to 24 months

• Surgical costs per device used

  1 Day

• Patient Outcomes: Post-operative Pain

  Post operative up to Day 9

• Patient Outcomes: Change in Pain

  Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24

• Patient Outcomes: Change in International Hip Outcome Tool (IHOT-12) Scores

  Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24

Study Arms (2)

Arthrosocpic labral repair

ACTIVE COMPARATOR

Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula.

Device: Modified hip capsule side fixed slotted cannula

Arthroscopic bone grafting

ACTIVE COMPARATOR

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

Interventions

Modified hip capsule side fixed slotted cannula DEVICE

Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.

Arthroscopic bone grafting; Arthrosocpic labral repair

Modified bone graft delivery tool set DEVICE

Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.

Arthroscopic bone grafting

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado, Hip Preservation Center, Orthopedic Department

Boulder, Colorado, 80304, United States

Location

UCHealth Steadman Hawkins Clinic - Denver

Englewood, Colorado, 80112, United States

Location

Related Publications (11)

• Beck M, Kalhor M, Leunig M, Ganz R. Hip morphology influences the pattern of damage to the acetabular cartilage: femoroacetabular impingement as a cause of early osteoarthritis of the hip. J Bone Joint Surg Br. 2005 Jul;87(7):1012-8. doi: 10.1302/0301-620X.87B7.15203.

  PMID: 15972923 BACKGROUND

• Zhang C, Li L, Forster BB, Kopec JA, Ratzlaff C, Halai L, Cibere J, Esdaile JM. Femoroacetabular impingement and osteoarthritis of the hip. Can Fam Physician. 2015 Dec;61(12):1055-60.

  PMID: 26668284 BACKGROUND

• Lung R, O'Brien J, Grebenyuk J, Forster BB, De Vera M, Kopec J, Ratzlaff C, Garbuz D, Prlic H, Esdaile JM. The prevalence of radiographic femoroacetabular impingement in younger individuals undergoing total hip replacement for osteoarthritis. Clin Rheumatol. 2012 Aug;31(8):1239-42. doi: 10.1007/s10067-012-1981-9. Epub 2012 May 3.

  PMID: 22552857 BACKGROUND

• Huo MH, Parvizi J, Bal BS, Mont MA; Council of Musculoskeletal Specialty Societies (COMSS) of the American Academy of Orthopaedic Surgeons. What's new in total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):2043-55. doi: 10.2106/JBJS.H.00741. No abstract available.

  PMID: 18762667 BACKGROUND

• Kelly BT, Williams RJ 3rd, Philippon MJ. Hip arthroscopy: current indications, treatment options, and management issues. Am J Sports Med. 2003 Nov-Dec;31(6):1020-37. doi: 10.1177/03635465030310060701.

  PMID: 14623676 BACKGROUND

• Philippon MJ, Stubbs AJ, Schenker ML, Maxwell RB, Ganz R, Leunig M. Arthroscopic management of femoroacetabular impingement: osteoplasty technique and literature review. Am J Sports Med. 2007 Sep;35(9):1571-80. doi: 10.1177/0363546507300258. Epub 2007 Apr 9.

  PMID: 17420508 BACKGROUND

• Huo MH, Parvizi J, Bal BS, Mont MA. What's new in total hip arthroplasty. J Bone Joint Surg Am. 2009 Oct;91(10):2522-34. doi: 10.2106/JBJS.I.00801. No abstract available.

  PMID: 19797590 BACKGROUND

• Leunig M, Werlen S, Ungersbock A, Ito K, Ganz R. Evaluation of the acetabular labrum by MR arthrography. J Bone Joint Surg Br. 1997 Mar;79(2):230-4. doi: 10.1302/0301-620x.79b2.7288.

  PMID: 9119848 BACKGROUND

• Tsai SW, Chen CF, Wu PK, Chen TH, Liu CL, Chen WM. Modified anterolateral approach in minimally invasive total hip arthroplasty. Hip Int. 2015 May-Jun;25(3):245-50. doi: 10.5301/hipint.5000218. Epub 2015 Feb 12.

  PMID: 25684250 BACKGROUND

• Wang Y, Xu H, Ding M, Zhen Z, Lu Q, Liao B, Shangguan L. Permanently Avoiding Steam on Camera for Arthroscopy by a Simple Device. Arthrosc Tech. 2018 Dec 17;8(1):e47-e49. doi: 10.1016/j.eats.2018.08.029. eCollection 2019 Jan.

  PMID: 30899650 BACKGROUND

• RStudio: Integrated Development for R. [computer program]. Version 1.1.456. Boston, MA: RStudio, Inc.; 2016

  BACKGROUND

Study Officials

• Omer Mei-Dan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: We will be utilizing anonymous staff surveys. After the staff within the operating room (scrub, circulator, PA, and fellow) completes the paper survey (following the procedure), the staff member (who did not use the device per specific surgery) will administer the survey and seal in an envelope, which will be sent to the PRA. Thus, these responses will be blinded to the PI.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: August 18, 2020
• Study Start: August 24, 2020
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)