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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Revalesio Corporation
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT01922427
First received: August 9, 2013
Last updated: July 24, 2014
Last verified: July 2014
  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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2014
Estimated Primary Completion Date: May 2015 (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
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, see Learn About Clinical Studies.

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: July 24, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014