Hip ArthroscopyNCT04516109
Modifications of Devices for Hip Arthroscopy
A study testing Modified hip capsule side fixed slotted cannula and Modified bone graft delivery tool set in people with Hip Arthroscopy, run by University of Colorado, Denver at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hip Arthroscopy
- What is being tested?
- Modified hip capsule side fixed slotted cannula and Modified bone graft delivery tool set
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Aug 2020to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Age <18 years.
- Prisoners.
- Pregnant women.
- Decisionally challenged.
- Does not speak or understand English.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado, Hip Preservation Center, Orthopedic Department
Boulder, Colorado, 80304
UCHealth Steadman Hawkins Clinic - Denver
Englewood, Colorado, 80112
About this study
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.
Read the 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.
- Conditions
- Hip Arthroscopy
- Being tested
- Modified hip capsule side fixed slotted cannula, Modified bone graft delivery tool set
- Keywords
- Hip arthroscopy, Arthroscopy, Labral repair, bone grafting, Total hip arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified hip capsule side fixed slotted cannulaDevice
Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.
Modified bone graft delivery tool setDevice
Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Arthrosocpic labral repair | Active comparator | Patients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula. Receives: 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. Receives: Device: Modified hip capsule side fixed slotted cannula; Device: Modified bone graft delivery tool set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 Day
Secondary outcomes (6)
Rate of Surgical Complications
Total number of complications determined to be related to the hip arthroscopy procedure.
Measured: Up to 24 months
Surgical costs per device used
Cost to use each device in surgery, measured in US dollars.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start24 Aug 2020
- Primary completionAug 2024 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hip ArthroscopyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Mei-Dan, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516109
- Sponsor's protocol ID
- 19-2755
- Status last verified
- Feb 2023
- First submitted
- 8 Jul 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15972923Zhang 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.
PubMed 26668284Lung 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.
PubMed 22552857Huo 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.
PubMed 18762667Kelly 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.
PubMed 14623676Philippon 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.
PubMed 17420508Huo 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.
PubMed 19797590Leunig 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.
PubMed 9119848Tsai 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.
PubMed 25684250Wang 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.
PubMed 30899650RStudio: Integrated Development for R. [computer program]. Version 1.1.456. Boston, MA: RStudio, Inc.; 2016
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications of Devices for Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT04516109
- Acronym / sponsor ID
- 19-2755
- Conditions
- Hip Arthroscopy
- Keywords
- Hip arthroscopy, Arthroscopy, Labral repair, bone grafting, Total hip arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arthrosocpic labral repair | Active comparator | Device: Modified hip capsule side fixed slotted cannulaPatients undergoing arthroscopic labral repair with the use of the modified hip capsule slotted cannula. |
| Arthroscopic bone grafting | Active comparator | Device: Modified hip capsule side fixed slotted cannula, Device: Modified bone graft delivery tool setPatients undergoing arthroscopic bone grafting of subchrondral cyst with the use of the modified bone graft delivery tool set and modified hip capsule slotted cannula. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Age <18 years.
- Prisoners.
- Pregnant women.
- Decisionally challenged.
- Does not speak or understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified hip capsule side fixed slotted cannulaModified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint. | Device | Arthroscopic bone grafting, Arthrosocpic labral repair |
| Modified bone graft delivery tool setModified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure. | Device | Arthroscopic bone grafting |
Primary outcome
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).
6 secondary outcomes
Rate of Surgical Complications
Time frame: Up to 24 months
Surgical costs per device used
Time frame: 1 Day
Patient Outcomes: Post-operative Pain
Time frame: 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
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
Patient Outcomes: Change in Non-Arthritic Hip Scores
Time frame: Pre-treatment, Week 6, Month 3, Month 6, Month 12, Month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 15972923Beck 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.
- Background: PubMed 26668284Zhang 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.
- Background: PubMed 22552857Lung 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.
- Background: PubMed 18762667Huo 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.
- Background: PubMed 14623676Kelly 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.
- Background: PubMed 17420508Philippon 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.
- Background: PubMed 19797590Huo 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.
- Background: PubMed 9119848Leunig 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.
- Background: PubMed 25684250Tsai 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.
- Background: PubMed 30899650Wang 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.
- BackgroundRStudio: Integrated Development for R. [computer program]. Version 1.1.456. Boston, MA: RStudio, Inc.; 2016
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Mei-Dan, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified hip capsule side fixed slotted cannula and Modified bone graft delivery tool set in people with Hip Arthroscopy, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time per technical phase measured in minutes (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516109, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.