Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417934
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease Intervention/treatment
Hip Disease Procedure: Hip Arthroscopy Procedure

Detailed 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Days
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
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417934


Locations
Layout table for location information
United States, Colorado
University of Colorado, Hip Preservation Center, Orthopedic Department
Boulder, Colorado, United States, 80304
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Omer Mei-Dan, MD University of Colorado, Denver
Additional Information:

Publications:
Byrd JW. Chapter 16. Complications associated with hip arthroscopy. In Operative Hip Arthroscopy (2nd edition); Springer: New York, 2005.
McCatihy JC, Lee J. Hip arthroscopy: indications, outcomes, and complications. AAOS Instructional Course Lecture. JBJS 2005; 87-A (5):1138-45.
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.
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.

Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03417934    
Other Study ID Numbers: 17-0930
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No