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Completed

NCT Number: NCT03417934

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Hip Preservation Center, Orthopedic Department

Boulder, Colorado, 80304, United States

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip Arthroscopy Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pre- and post-operative screening for DVT.

    Time frame: 12 Days

    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.

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

    Time frame: 12 Days

    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.

  3. Blood Flow Alterations

    Time frame: 12 Days

    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).

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 31, 2018
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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