NCT03417934

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

January 19, 2018

Last Update Submit

July 31, 2019

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Days

Secondary Outcomes (3)

  • Pre- and post-operative screening for DVT.

    12 Days

  • Estimate the amount of tissue/muscle damage associated with hip arthroscopy procedures.

    12 Days

  • Blood Flow Alterations

    12 Days

Interventions

Hip Arthroscopy ProcedurePROCEDURE

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Hip Preservation Center, Orthopedic Department

Boulder, Colorado, 80304, United States

Location

Related Publications (22)

  • 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: 9195032BACKGROUND

  • Kelly BT, Buly RL. Hip arthroscopy update. HSS J. 2005 Sep;1(1):40-8. doi: 10.1007/s11420-005-0105-3.

    PMID: 18751808BACKGROUND

  • 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: 18063180BACKGROUND

  • 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: 3960759BACKGROUND

  • 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: 29244523BACKGROUND

  • 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.

    PMID: 10463728BACKGROUND

  • Byrd JW. Chapter 16. Complications associated with hip arthroscopy. In Operative Hip Arthroscopy (2nd edition); Springer: New York, 2005.

    BACKGROUND

  • 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: 19018604BACKGROUND

  • McCarthy JC, Lee JA. Hip arthroscopy: indications, outcomes, and complications. Instr Course Lect. 2006;55:301-8.

    PMID: 16958465BACKGROUND

  • 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: 18442695BACKGROUND

  • 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: 19226026BACKGROUND

  • 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: 15125862BACKGROUND

  • 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: 18684675BACKGROUND

  • 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: 8792251BACKGROUND

  • 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: 9437378BACKGROUND

  • 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: 11583313BACKGROUND

  • 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.

    PMID: 14507948BACKGROUND

  • 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.

    BACKGROUND

  • 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: 15189396BACKGROUND

  • 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.

    PMID: 2678243BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 22920287BACKGROUND

Study Officials

  • Omer Mei-Dan, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 31, 2018

Study Start

January 8, 2018

Primary Completion

August 13, 2018

Study Completion

August 13, 2018

Last Updated

August 1, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)