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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hip Disease

Treatments: Procedure: Hip Arthroscopy Procedure

Study type: Observational

Funder types: Other

Identifiers

NCT03417934

17-0930

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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