Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction

Hip Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03417934
• Other study ID #: 17-0930
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: August 13, 2018

Study information

• Verified date: July 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hip Disease

Intervention

Procedure:
• Hip Arthroscopy Procedure
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.

Locations

Country	Name	City	State
United States	University of Colorado, Hip Preservation Center, Orthopedic Department	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (22)

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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.

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. Review. — View Citation

Bushnell BD, Dahners LE. Fatal pulmonary embolism in a polytraumatized patient following hip arthroscopy. Orthopedics. 2009 Jan;32(1):56. — View Citation

Byrd JW, Chern KY. Traction versus distension for distraction of the joint during hip arthroscopy. Arthroscopy. 1997 Jun;13(3):346-9. — View Citation

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

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. — View 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. — View 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. — View 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.

Eriksson E, Arvidsson I, Arvidsson H. Diagnostic and operative arthroscopy of the hip. Orthopedics. 1986 Feb;9(2):169-76. — View 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. Review. — View 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. — View Citation

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

McCatihy JC, Lee J. Hip arthroscopy: indications, outcomes, and complications. AAOS Instructional Course Lecture. JBJS 2005; 87-A (5):1138-45.

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. — View Citation

Merritt CR. Ultrasound safety: what are the issues? Radiology. 1989 Nov;173(2):304-6. — View 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. — View 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. Epub 2007 Oct 3. Review. — View 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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 Days
Secondary	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.	12 Days
Secondary	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).	12 Days