Study of RNS60 on Pain and Function After Knee Anterior Cruciate Ligament Surgery

This study is not yet open for participant recruitment.
Verified December 2013 by Revalesio Corporation
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT01922427
First received: August 9, 2013
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction
Drug: RNS60
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Knee Anterior Cruciate Reconstruction Surgery

Resource links provided by NLM:


Further study details as provided by Revalesio Corporation:

Primary Outcome Measures:
  • Assessment of post-operative pain [ Time Frame: 1 week ]

Estimated Enrollment: 24
Study Start Date: January 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RNS60
RNS60 given intra-articularly as the last 1 liter of irrigation + peripheral i.v. administration.
Drug: RNS60
Placebo Comparator: Saline
Saline given intra-articularly as the last 1 liter of irrigation + peripheral i.v. administration.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ACL reconstruction surgery of the knee.
  • ACL injury occurred no more than 12 months prior to surgery.

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.
  • Concomitant Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL), Posterior Cruciate Ligament (PCL) injury, or meniscus tear on the relevant knee.
  • Previous surgery on the relevant knee or concomitant surgery on other joints.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01922427

Locations
United States, Colorado
Steadman Philippon Research Clinic Not yet recruiting
Vail, Colorado, United States, 81657
Contact: Karen Briggs, MPH    970-479-5783      
Principal Investigator: Robert LaPrade, M.D., PhD         
Sponsors and Collaborators
Revalesio Corporation
  More Information

No publications provided

Responsible Party: Revalesio Corporation
ClinicalTrials.gov Identifier: NCT01922427     History of Changes
Other Study ID Numbers: 07.1.1.H1
Study First Received: August 9, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 15, 2014