Modifications of Devices for Hip Arthroscopy

Hip Arthroscopy Clinical Trial

Official title:

Modifications of Devices for Hip Arthroscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04516109
• Other study ID #: 19-2755
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: August 2026

Study information

• Verified date: February 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 111
• Est. completion date: August 2026
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Arthroscopy

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado, Hip Preservation Center, Orthopedic Department	Boulder	Colorado
United States	UCHealth Steadman Hawkins Clinic - Denver	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Bone Joint Surg Br 1997 Jul;79(4):693. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Surgical Complications	Total number of complications determined to be related to the hip arthroscopy procedure.	Up to 24 months
Secondary	Surgical costs per device used	Cost to use each device in surgery, measured in US dollars.	1 Day
Secondary	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.	Post operative up to Day 9
Secondary	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.	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Secondary	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.	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Secondary	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.	Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24