Hip DiseaseNCT03417934
Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction
An observational study of Hip Disease, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hip Disease
- What is being tested?
- Hip Arthroscopy Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 13 Aug 2018
- How long will I take part?
- 12 Days
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population description is to include male or female subjects between the ages of 18 and 65 years, inclusively, with an election to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed).
Who may be able to join
- Male or female between 18 and 65 years of age inclusively
- Has elected to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed)
- Is able to give voluntary, written informed consent to participate in this clinical investigation and has signed an informed consent document
Who cannot join
- Any major systemic or lower extremity trauma, or any preexisting medical condition/illness that represents a contraindication for hip arthroscopy surgery
- Significant peripheral vascular disease characterized by diminished dorsalis pedis or tibial pulse
- Significant peripheral neuropathy demonstrated by nerve conduction velocity test
- Preoperative use of statins or other medications known to elevate serum CPK-MM levels within one week of surgery
- Total hip replacement of the indicated hip(s)
- History of substance abuse within past 12 months (this includes any chronic narcotic use)
- Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the informed consent process
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado, Hip Preservation Center, Orthopedic Department
Boulder, Colorado, 80304
About this study
Official title: Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
Read the detailed description
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. The data from this exploratory study can be used to help develop estimates of the proportions of patients who experience significant venous/nerve/tissue compromise in the lower extremity as a result of the application of traction forces necessary to achieve hip joint distraction, and may serve as a basis for sample size planning in future studies comparing the effects of various methods of hip distraction techniques during hip arthroscopy.
- Conditions
- Hip Disease
- Being tested
- Hip Arthroscopy Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip Arthroscopy ProcedureProcedure or surgery
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures.
Routine intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures will result in significant blood flow alterations as measured by Doppler ultrasonography.
Measured: 12 Days
Secondary outcomes (3)
Pre- and post-operative screening for DVT.
Pre- and post-operative screening for Deep Vein Thrombosis (DVT) using the D-Dimer assay test is correlative with intra-operative venous blood flow measurements.
Measured: 12 Days
Estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures.
To quantitatively estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures using creatine phosphokinase (CPK-MM) serum levels as a prognostic marker.
Measured: 12 Days
Blood Flow Alterations
To determine whether routine intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures results in significant blood flow alterations as measured by significant changes in peripheral nerve conduction as measured by Somatosensory Evoked Potentials (SSEP).
Measured: 12 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start8 Jan 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Hip DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 12 Days
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
- NCT03417934
- Sponsor's protocol ID
- 17-0930
- Status last verified
- Jul 2019
- First submitted
- 19 Jan 2018
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byrd JW, Chern KY. Traction versus distension for distraction of the joint during hip arthroscopy. Arthroscopy. 1997 Jun;13(3):346-9. doi: 10.1016/s0749-8063(97)90032-3.
PubMed 9195032Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.
PubMed 18751808Smart LR, Oetgen M, Noonan B, Medvecky M. Beginning hip arthroscopy: indications, positioning, portals, basic techniques, and complications. Arthroscopy. 2007 Dec;23(12):1348-53. doi: 10.1016/j.arthro.2007.06.020. Epub 2007 Oct 3.
PubMed 18063180Eriksson E, Arvidsson I, Arvidsson H. Diagnostic and operative arthroscopy of the hip. Orthopedics. 1986 Feb;9(2):169-76. doi: 10.3928/0147-7447-19860201-07.
PubMed 3960759Mei-Dan O, Kraeutler MJ, Garabekyan T, Goodrich JA, Young DA. Hip Distraction Without a Perineal Post: A Prospective Study of 1000 Hip Arthroscopy Cases. Am J Sports Med. 2018 Mar;46(3):632-641. doi: 10.1177/0363546517741704. Epub 2017 Dec 15.
PubMed 29244523Baber YF, Robinson AH, Villar RN. Is diagnostic arthroscopy of the hip worthwhile? A prospective review of 328 adults investigated for hip pain. J Bone Joint Surg Br. 1999 Jul;81(4):600-3. doi: 10.1302/0301-620x.81b4.8803.
PubMed 10463728Byrd JW. Chapter 16. Complications associated with hip arthroscopy. In Operative Hip Arthroscopy (2nd edition); Springer: New York, 2005.
Ilizaliturri VM Jr. Complications of arthroscopic femoroacetabular impingement treatment: a review. Clin Orthop Relat Res. 2009 Mar;467(3):760-8. doi: 10.1007/s11999-008-0618-4. Epub 2008 Nov 19.
PubMed 19018604McCarthy JC, Lee JA. Hip arthroscopy: indications, outcomes, and complications. Instr Course Lect. 2006;55:301-8.
PubMed 16958465Bushnell BD, Anz AW, Bert JM. Venous thromboembolism in lower extremity arthroscopy. Arthroscopy. 2008 May;24(5):604-11. doi: 10.1016/j.arthro.2007.11.010. Epub 2008 Jan 7.
PubMed 18442695Bushnell BD, Dahners LE. Fatal pulmonary embolism in a polytraumatized patient following hip arthroscopy. Orthopedics. 2009 Jan;32(1):56. doi: 10.3928/01477447-20090101-01.
PubMed 19226026Jones SC, Fernau R, Woeltjen BL. Use of somatosensory evoked potentials to detect peripheral ischemia and potential injury resulting from positioning of the surgical patient: case reports and discussion. Spine J. 2004 May-Jun;4(3):360-2. doi: 10.1016/j.spinee.2003.08.023.
PubMed 15125862Chung I, Glow JA, Dimopoulos V, Walid MS, Smisson HF, Johnston KW, Robinson JS, Grigorian AA. Upper-limb somatosensory evoked potential monitoring in lumbosacral spine surgery: a prognostic marker for position-related ulnar nerve injury. Spine J. 2009 Apr;9(4):287-95. doi: 10.1016/j.spinee.2008.05.004. Epub 2008 Aug 5.
PubMed 18684675Pereles TR, Stuchin SA, Kastenbaum DM, Beric A, Lacagnino G, Kabir H. Surgical maneuvers placing the sciatic nerve at risk during total hip arthroplasty as assessed by somatosensory evoked potential monitoring. J Arthroplasty. 1996 Jun;11(4):438-44. doi: 10.1016/s0883-5403(96)80034-9.
PubMed 8792251Demers C, Marcoux S, Ginsberg JS, Laroche F, Cloutier R, Poulin J. Incidence of venographically proved deep vein thrombosis after knee arthroscopy. Arch Intern Med. 1998 Jan 12;158(1):47-50. doi: 10.1001/archinte.158.1.47.
PubMed 9437378
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study
- ClinicalTrials.gov ID
- NCT03417934
- Acronym / sponsor ID
- 17-0930
- Conditions
- Hip Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 31 Jan 2018 (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.
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
Detailed description
The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. The data from this exploratory study can be used to help develop estimates of the proportions of patients who experience significant venous/nerve/tissue compromise in the lower extremity as a result of the application of traction forces necessary to achieve hip joint distraction, and may serve as a basis for sample size planning in future studies comparing the effects of various methods of hip distraction techniques during hip arthroscopy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Days
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population description is to include male or female subjects between the ages of 18 and 65 years, inclusively, with an election to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed).
Key inclusion criteria (3 listed)
- Male or female between 18 and 65 years of age inclusively
- Has elected to undergo a standard hip arthroscopic procedure that is expected to require access to the central compartment of the hip joint (bilateral hip enrollment is allowed)
- Is able to give voluntary, written informed consent to participate in this clinical investigation and has signed an informed consent document
Key exclusion criteria (7 listed)
- Any major systemic or lower extremity trauma, or any preexisting medical condition/illness that represents a contraindication for hip arthroscopy surgery
- Significant peripheral vascular disease characterized by diminished dorsalis pedis or tibial pulse
- Significant peripheral neuropathy demonstrated by nerve conduction velocity test
- Preoperative use of statins or other medications known to elevate serum CPK-MM levels within one week of surgery
- Total hip replacement of the indicated hip(s)
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 |
|---|---|---|
| Hip Arthroscopy ProcedureThe purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury. | Procedure or surgery | – |
Primary outcome
Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures.
Time frame: 12 Days
Routine intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures will result in significant blood flow alterations as measured by Doppler ultrasonography.
3 secondary outcomes
Pre- and post-operative screening for DVT.
Time frame: 12 Days
Estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures.
Time frame: 12 Days
Blood Flow Alterations
Time frame: 12 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Background: PubMed 9195032Byrd JW, Chern KY. Traction versus distension for distraction of the joint during hip arthroscopy. Arthroscopy. 1997 Jun;13(3):346-9. doi: 10.1016/s0749-8063(97)90032-3.
- Background: PubMed 18751808Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.
- Background: PubMed 18063180Smart LR, Oetgen M, Noonan B, Medvecky M. Beginning hip arthroscopy: indications, positioning, portals, basic techniques, and complications. Arthroscopy. 2007 Dec;23(12):1348-53. doi: 10.1016/j.arthro.2007.06.020. Epub 2007 Oct 3.
- Background: PubMed 3960759Eriksson E, Arvidsson I, Arvidsson H. Diagnostic and operative arthroscopy of the hip. Orthopedics. 1986 Feb;9(2):169-76. doi: 10.3928/0147-7447-19860201-07.
- Background: PubMed 29244523Mei-Dan O, Kraeutler MJ, Garabekyan T, Goodrich JA, Young DA. Hip Distraction Without a Perineal Post: A Prospective Study of 1000 Hip Arthroscopy Cases. Am J Sports Med. 2018 Mar;46(3):632-641. doi: 10.1177/0363546517741704. Epub 2017 Dec 15.
- Background: PubMed 10463728Baber YF, Robinson AH, Villar RN. Is diagnostic arthroscopy of the hip worthwhile? A prospective review of 328 adults investigated for hip pain. J Bone Joint Surg Br. 1999 Jul;81(4):600-3. doi: 10.1302/0301-620x.81b4.8803.
- BackgroundByrd JW. Chapter 16. Complications associated with hip arthroscopy. In Operative Hip Arthroscopy (2nd edition); Springer: New York, 2005.
- Background: PubMed 19018604Ilizaliturri VM Jr. Complications of arthroscopic femoroacetabular impingement treatment: a review. Clin Orthop Relat Res. 2009 Mar;467(3):760-8. doi: 10.1007/s11999-008-0618-4. Epub 2008 Nov 19.
- Background: PubMed 16958465McCarthy JC, Lee JA. Hip arthroscopy: indications, outcomes, and complications. Instr Course Lect. 2006;55:301-8.
- Background: PubMed 18442695Bushnell BD, Anz AW, Bert JM. Venous thromboembolism in lower extremity arthroscopy. Arthroscopy. 2008 May;24(5):604-11. doi: 10.1016/j.arthro.2007.11.010. Epub 2008 Jan 7.
- Background: PubMed 19226026Bushnell BD, Dahners LE. Fatal pulmonary embolism in a polytraumatized patient following hip arthroscopy. Orthopedics. 2009 Jan;32(1):56. doi: 10.3928/01477447-20090101-01.
- Background: PubMed 15125862Jones SC, Fernau R, Woeltjen BL. Use of somatosensory evoked potentials to detect peripheral ischemia and potential injury resulting from positioning of the surgical patient: case reports and discussion. Spine J. 2004 May-Jun;4(3):360-2. doi: 10.1016/j.spinee.2003.08.023.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Disease, run by University of Colorado, Denver at 1 site 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures. (time frame: 12 Days). 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 NCT03417934, which also lists 22 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 1 Aug 2019.