Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:13 AM
Study NCT ID:
NCT03417934
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2018-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'targetDuration': '12 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2018-01-19', 'studyFirstSubmitQcDate': '2018-01-30', 'lastUpdatePostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-operative application of hip distraction without a perineal post to the lower extremity during hip arthroscopy procedures.', 'timeFrame': '12 Days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pre- and post-operative screening for DVT.', 'timeFrame': '12 Days', 'description': '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.'}, {'measure': 'Estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures.', 'timeFrame': '12 Days', 'description': '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.'}, {'measure': 'Blood Flow Alterations', 'timeFrame': '12 Days', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Disease']}, 'referencesModule': {'references': [{'pmid': '9195032', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18751808', 'type': 'BACKGROUND', 'citation': 'Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.'}, {'pmid': '18063180', 'type': 'BACKGROUND', 'citation': 'Smart 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.'}, {'pmid': '3960759', 'type': 'BACKGROUND', 'citation': 'Eriksson 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.'}, {'pmid': '29244523', 'type': 'BACKGROUND', 'citation': 'Mei-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.'}, {'pmid': '10463728', 'type': 'BACKGROUND', 'citation': 'Baber 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.'}, {'type': 'BACKGROUND', 'citation': 'Byrd JW. Chapter 16. Complications associated with hip arthroscopy. In Operative Hip Arthroscopy (2nd edition); Springer: New York, 2005.'}, {'pmid': '19018604', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16958465', 'type': 'BACKGROUND', 'citation': 'McCarthy JC, Lee JA. Hip arthroscopy: indications, outcomes, and complications. Instr Course Lect. 2006;55:301-8.'}, {'pmid': '18442695', 'type': 'BACKGROUND', 'citation': 'Bushnell 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.'}, {'pmid': '19226026', 'type': 'BACKGROUND', 'citation': 'Bushnell 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.'}, {'pmid': '15125862', 'type': 'BACKGROUND', 'citation': 'Jones 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.'}, {'pmid': '18684675', 'type': 'BACKGROUND', 'citation': 'Chung 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.'}, {'pmid': '8792251', 'type': 'BACKGROUND', 'citation': 'Pereles 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.'}, {'pmid': '9437378', 'type': 'BACKGROUND', 'citation': 'Demers 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.'}, {'pmid': '11583313', 'type': 'BACKGROUND', 'citation': 'Delis KT, Hunt N, Strachan RK, Nicolaides AN. Incidence, natural history and risk factors of deep vein thrombosis in elective knee arthroscopy. Thromb Haemost. 2001 Sep;86(3):817-21.'}, {'pmid': '14507948', 'type': 'BACKGROUND', 'citation': 'Wells PS, Anderson DR, Rodger M, Forgie M, Kearon C, Dreyer J, Kovacs G, Mitchell M, Lewandowski B, Kovacs MJ. Evaluation of D-dimer in the diagnosis of suspected deep-vein thrombosis. N Engl J Med. 2003 Sep 25;349(13):1227-35. doi: 10.1056/NEJMoa023153.'}, {'type': 'BACKGROUND', 'citation': 'Ennis RS. Deep Venous Thrombosis Prophylaxis in Orthopedic Surgery. eMedicine; June 12, 2009. http)/emedicine.medscape.com/article/1268573-overview. Webpage accessed December 8, 2009.'}, {'pmid': '15189396', 'type': 'BACKGROUND', 'citation': 'Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.'}, {'pmid': '2678243', 'type': 'BACKGROUND', 'citation': 'Merritt CR. Ultrasound safety: what are the issues? Radiology. 1989 Nov;173(2):304-6. doi: 10.1148/radiology.173.2.2678243. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'BlueCross BlueShield of Texas. Intra-operative Neurophysiologic Monitoring (Sensory-Evoked Potentials, Motor Evoked Potentials, EMG Monitoring). Medical Policy Bulletin (MED 205.011); Effective Date: 12/11/03.'}, {'pmid': '22920287', 'type': 'BACKGROUND', 'citation': 'Martin HD, Palmer IJ, Champlin K, Kaiser B, Kelly B, Leunig M. Physiological changes as a result of hip arthroscopy performed with traction. Arthroscopy. 2012 Oct;28(10):1365-72. doi: 10.1016/j.arthro.2012.04.139. Epub 2012 Aug 21.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between 18 and 65 years of age inclusively\n* 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)\n* Is able to give voluntary, written informed consent to participate in this clinical investigation and has signed an informed consent document\n\nExclusion Criteria:\n\n* Any major systemic or lower extremity trauma, or any preexisting medical condition/illness that represents a contraindication for hip arthroscopy surgery\n* Significant peripheral vascular disease characterized by diminished dorsalis pedis or tibial pulse\n* Significant peripheral neuropathy demonstrated by nerve conduction velocity test\n* Preoperative use of statins or other medications known to elevate serum CPK-MM levels within one week of surgery\n* Total hip replacement of the indicated hip(s)\n* History of substance abuse within past 12 months (this includes any chronic narcotic use)\n* Any significant psychological disturbance past or present, psychotic or neurotic, that could impair the informed consent process'}, 'identificationModule': {'nctId': 'NCT03417934', 'briefTitle': 'Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study', 'orgStudyIdInfo': {'id': '17-0930'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hip Arthroscopy Procedure', 'type': 'PROCEDURE', '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80304', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado, Hip Preservation Center, Orthopedic Department', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}], 'overallOfficials': [{'name': 'Omer Mei-Dan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}