Clinical Trials Logo
  1. Home
  2. Knee Injuries
  3. NCT00226759

Efficacy and Safety of OMS103HP in Patients Undergoing Allograft Anterior Cruciate Ligament (ACL) Reconstruction

Knee Injuries Clinical Trial

Official title:
Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Allograft ACL Reconstruction

Clinical Trial Summary

The anterior cruciate ligament (ACL) is an important stabilizer of the knee. Orthopedic surgeons replace the torn ligament during ACL reconstruction surgery. Surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. OMS103HP was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin.

The purpose of this study is to assess the effectiveness and safety of OMS103HP in improving knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00226759
Study type Interventional
Source Omeros Corporation
Contact
Status Completed
Phase Phase 3
Start date November 2004
Completion date March 2011
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04554212 - Blood Flow Restriction Training After Patellar INStability N/A
Completed NCT04815980 - Impact of Pilates on Running Mechanics N/A
Not yet recruiting NCT05484778 - Analysis of Balance and Functional Hop Tests Used for Return to Sports in Athletes With Lower Extremity Injuries by Dual Task Study N/A
Terminated NCT02909257 - Motor-Sparing Femoral Nerve Block Dose Phase 4
Completed NCT02540811 - Clinical Evaluation of dCELL® ACL Scaffold for Reconstruction of the Anterior Cruciate Ligament N/A
Recruiting NCT03755388 - Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant N/A
Recruiting NCT00174213 - Validity and Reliability in Measuring Iliotibial Tract by Using Ultrasound Phase 1
Completed NCT03202901 - Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers N/A
Completed NCT06206018 - Patient-Reported Outcome Measures in Lower Extremity Rehabilitation Program PROM_R: Impact on Health Care N/A
Completed NCT04543227 - Opioid Laws and Pediatric Use
Completed NCT06078072 - Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions
Completed NCT04956393 - The SOAR (Stop OsteoARthritis) Program Proof-of-Concept Study N/A
Recruiting NCT06451510 - Knee Osteoarthritis in the Region of Norrbotten
Completed NCT04118023 - 7T MRI to Evaluate Cartilage Defects in the Knee
Completed NCT03486405 - A Randomized Control Trial: Returning to Run After Injury N/A
Recruiting NCT03858231 - Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery Phase 4
Recruiting NCT02918734 - Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws N/A
Suspended NCT02270905 - Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus N/A
Completed NCT01227694 - Adult Stem Cell Therapy for Repairing Articular Cartilage in Gonarthrosis Phase 1/Phase 2
Completed NCT00991588 - Clinical Outcome of Posterior Cruciate Ligament (PCL) Posterolateral Reconstruction