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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

OMS103HP is being developed for improvement in knee function following ACL reconstruction. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee motion and earlier return to work.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00226759

Knee Injuries

COMPLETED PHASE3

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

NCT00226772

Knee Injuries

COMPLETED PHASE3

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee.

NCT00821873

Knee Injury

COMPLETED PHASE3

Evaluation After Reconstruction of the Anterior Cruciate Ligament of the Knee Using the Bioresorbable Interference Screw (SMS): Resorbability, Per- and Post-operative Complications and Articular Functional Recovery.

NCT03529552

Anterior Cruciate Ligament Rupture

TERMINATED NA

Follow-up Study of Chondrogen® Delivered by Intra-Articular Injection Following Meniscectomy

NCT00702741

Recovery Following Partial Medial Meniscectomy

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. Because of the dynamic nature, complexity and redundancy of the chemical mediators of inflammation and pain and their pathways, no currently available single drug has sufficiently broad spectrum of activity to effectively inhibit the inflammatory process. OMS103 provides a multicomponent approach to controlling the inflammation induced by arthroscopic surgery. It delivers three active ingredients, each with distinct pharmacological activities, directly to the site of surgical procedures to preemptively block the inflammatory cascade induced by surgical trauma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anterior Cruciate Ligament Reconstruction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

OMS103 Irrigation Solution

Group Type EXPERIMENTAL

OMS103HP

Intervention Type DRUG

Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours

2

Balanced Salt Solution (BSS)

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OMS103HP

Maximum of 13 bags of OMS103HP irrigation solution over a maximum of 2 hours

Intervention Type DRUG

Vehicle

Maximum of 13 bags of BSS irrigation over a maximum of 2 hours.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 17 - 65 years of age
* In good general health
* Undergoing arthroscopic ACL reconstruction for an ACL tear

Exclusion Criteria

* Allergies to any of the individual ingredients in OMS103HP
* Has open physes in the distal femur or proximal tibia
* Undergoing bilateral knee surgery
* Subject who is considered by Investigator to be an unsuitable candidate

Minimum Eligible Age

17 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No