Knee InjuriesPhase 3NCT00226772
Efficacy and Safety of OMS103HP in Patients Undergoing Autograft Anterior Cruciate Ligament (ACL) Reconstruction
A Phase 3 study testing OMS103HP in people with Knee Injuries, run by Omeros Corporation at 18 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- OMS103HP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jun 2005to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 15 - 65 years of age
- In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
- Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft
- Able to participate in the study rehabilitation protocol
- and other inclusion criteria
Who cannot join
- Allergies to any of the individual ingredients in OMS103HP
- Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
- Associated knee injuries likely to interfere with evaluation of the study drug
- and other exclusion criteria
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States15 sites
University Orthopedics Center - Altoona
Altoona, Pennsylvania, 16602
Texas Orthopedics
Austin, Texas, 78759
Advanced Orthopedic and Sports Medicine Specialists
Denver, Colorado, 80230
CORE Orthopaedic Medical Center
Encinitas, California, 92024
Colorado Orthopedic Consultants, PC
Englewood, Colorado, 80110
University of Florida
Gainesville, Florida, 32611
Minnesota Sports Medicine
Minneapolis, Minnesota, 55454
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708
Round Rock Orthopedics
Round Rock, Texas, 78681
William Beaumont Hospital
Royal Oak, Michigan, 48073
Unlimited Research
San Antonio, Texas, 78217
Hill Country Sports Medicine
San Marcos, Texas, 78666
University Orthopedics Center
State College, Pennsylvania, 16801
Madigan Army Medical Center
Tacoma, Washington, 98431
Canada3 sites
Rouge Valley Health Systems
Ajax, Ontario, L1S 2J5
Lifemark Health Research Group
Calgary, Alberta, T2G 5B6
Fowler Kennedy Sport Medicine Clinic
London, Ontario, N6A 3K7
About this study
Official title: Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction
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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.
- Conditions
- Knee Injuries
- Being tested
- OMS103HP, Vehicle
- Keywords
- Anterior cruciate ligament reconstruction, ACL reconstruction
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS103HPDrug
Maximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours
VehicleDrug
Maximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours
| Study group | Role | What they receive |
|---|---|---|
| OMS103HP irrigation solution | Experimental | Drug Receives: Drug: OMS103HP |
| vehicle irrigation solution | Placebo comparator | Vehicle Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in knee function
Measured: 30 days
Secondary outcomes (3)
Decreased pain
Measured: 30 days
Improved range of motion
Measured: 30 days
Earlier return to work
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionSep 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omeros Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Houston, Study director, Omeros Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226772
- Sponsor's protocol ID
- C03512
- Status last verified
- Oct 2012
- First submitted
- 26 Sep 2005
- Last updated
- 12 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Multicenter Phase 3 Study Comparing the Efficacy and Safety of OMS103HP With Vehicle in Patients Undergoing Autograft ACL Reconstruction
- ClinicalTrials.gov ID
- NCT00226772
- Acronym / sponsor ID
- C03512
- Conditions
- Knee Injuries
- Keywords
- Anterior cruciate ligament reconstruction, ACL reconstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Omeros CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 using a hamstring autograft. Secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion, and earlier return to work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OMS103HP irrigation solution | Experimental | Drug: OMS103HPDrug |
| vehicle irrigation solution | Placebo comparator | Drug: VehicleVehicle |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 15 - 65 years of age
- In good general health with an ACL tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery
- Undergoing primary unilateral ACL reconstruction using a medial hamstring (semitendinosus and gracilis) autograft
- Able to participate in the study rehabilitation protocol
- and other inclusion criteria
Key exclusion criteria (4 listed)
- Allergies to any of the individual ingredients in OMS103HP
- Taking medications with the same activities as that of the active ingredients in OMS103HP for defined time intervals prior to and after surgery
- Associated knee injuries likely to interfere with evaluation of the study drug
- and other exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMS103HPMaximum of 39 liters of OMS103HP irrigation solution over a maximum of 2 hours | Drug | OMS103HP irrigation solution |
| VehicleMaximum of 39 liters of vehicle irrigation solution over a maximum of 2 hours | Drug | vehicle irrigation solution |
Primary outcome
Improvement in knee function
Time frame: 30 days
3 secondary outcomes
Decreased pain
Time frame: 30 days
Improved range of motion
Time frame: 30 days
Earlier return to work
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2012.
Related trials for Knee Injuries
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Houston study director
Omeros Corporation
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OMS103HP in people with Knee Injuries, run by Omeros Corporation at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in knee function (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2012.