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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction During Hip Arthroscopic Procedures Clinical Protocol: Prospective Study

Conditions
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Hip Disease

Intervention / Treatment
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* Procedure: Hip Arthroscopy Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |