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. 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.

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