Study of RNS60 on Pain and Function After Hip Labral Repair



Status:Not yet recruiting
Healthy:No
Age Range:18 - 50
Updated:2/7/2015
Start Date:October 2014

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Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Hip Labral Repair or Reconstruction Surgery

The purpose of this study is to see if use of RNS60 during hip labral repair surgery
decreases pain and improves functional capacity post-operation.


Inclusion Criteria:

- Medically stable as determined by the Investigator.

- Normal 12-lead ECG prior to surgery.

- Women of childbearing potential who have a negative pregnancy test (urine HCG) before
surgery.

- Capable of understanding the purpose and risks of the study and provide written,
informed consent.

- Patients scheduled to undergo labral repair surgery of the hip.

Exclusion Criteria:

- Morbid obesity.

- History of any clinically significant autoimmune disease: inflammatory bowel disease,
diabetes, lupus or severe asthma.

- Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ
carcinoma of the cervix that has been adequately treated).

- Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver,
central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or
metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of
normal), history of myocardial infarction, congestive heart failure, or arrhythmias
within 6 months prior to enrollment.

- Steroid therapy within 60 days prior to enrollment.

- Use of any immunomodulatory drugs during the study.

- Participation in any investigational therapy within one year prior to enrollment,
unless given approval by PI.

- Known or suspected current or past alcohol or drug abuse within one year prior to
enrollment.

- Any medical, psychiatric or other condition that could result in a subject not being
able to comply with protocol requirements.

- Evidence of hip dysplasia and/or advanced hip osteoarthritis

- Previous trauma or surgery on the relevant hip.
We found this trial at
1
site
Vail, Colorado 81657
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Vail, CO
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