Anterior Cruciate LigamentEarly Phase 1HEALRNCT03429140
Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
A Early Phase 1 study testing Gel-One in people with Anterior Cruciate Ligament, run by Cale Jacobs, PhD at 1 site in United States.
Trial summary
This research study is designed to allow the investigator to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. Read more about this study
- Who is it for?
- Ages 14 to 33 years
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- Gel-One
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2017to 23 Jun 2019
- Phase
- Early Phase 1
- 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 14 to 33 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 14-33 years of age
- Currently participating in a sporting activity
- ACL injury occurred while playing in a sporting activity
- Normal contralateral knee status
- Documentation of closed growth plates as noted on the screening x-rays
Who cannot join
- Underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
- Currently have any infections, including infection of the skin, or have signs and symptoms of an infection, including fever
- Have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
- Other major medical condition requiring treatment with immunosuppressant or modulating drugs
- A history of chronic use of non-steroidal anti-inflammatory drugs
- Received corticosteroid injections into the injured knee within three months of enrollment
Show all 10Show fewer
- History of allergic reaction to hyaluronan injections
- Previous exposure or allergic reaction to Kenalog®
- Prior knee surgery (Ipsilateral or contralateral)
- Have received any investigational drug with 4 weeks of study Visit 1
Trial locations and contacts
1 site in 1 country.
United States1 site
UK Healthcare at Turfland
Lexington, Kentucky, 40504
About this study
This research study is designed to allow the investigator to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis.
The purpose of this research is to gather information on how safe and effective Gel-One is in alleviating knee pain following ACL surgery.
Read the detailed description
This is a single-center, placebo-controlled, double-blinded, randomized controlled trial.
This trial will be conducted at the University of Kentucky's Orthopaedic and Sports Medicine Center (Turfland Facility), with subjects being recruited from the patient populations of UK's Sports Medicine surgeons (Drs. Christian Lattermann, Darren Johnson, Mary Lloyd Ireland, and Scott Mair) during regularly schedule office visits.
After providing informed consent, subjects will be randomized into one of two groups, and there will be 19 subjects per group. All groups will receive standard of care aspiration and triamcinolone injection (40mg, Kenalog) within 1-10 days after ACL injury. The subjects will undergo initial standard of care pre-habilitation as deemed necessary by the surgeon and will undergo ACL reconstruction surgery. Knee aspiration will be performed 7-10 days after ACL reconstruction surgery and the patients will be randomized into 1 of 2 groups:
- Group 1: will receive injection of Gel-One (3ml 30mg Hyaluronan)
- Group 2: will receive an injection of 3ml of a saline placebo
Knee Aspiration: All subjects will undergo a total of four aspirations.
Visit Schedule and Procedures:
Visit 1 Screening (1-10 days post injury): Upon arriving at the clinic potential subjects will have the following assessments: range of motion, knee instability (Lachman's test) and standardized Flexion weight bearing x-rays, all of which are the standard of care for a patient with a suspected ACL injury. After providing informed consent to participate in the study, subjects will be asked to fill in standard questionnaires.
Collection of urine and 10 cc of blood for laboratory testing, partial Medical history, concomitant medications, demographic information, body mass index (BMI) measurement, smoking status, and questions will be collected. Scheduling for study-related magnet resonance imaging (MRI) scans.
Visit 2 (day of surgery)
- Lab specimens collected (urine and 10cc of blood)
- Pain Questionnaires administered prior to surgery
- Knee aspiration (in the operating room under anesthesia, both knees)
- Patient reported outcomes (PROs) administered prior to surgery
Visit 3 (1-2 weeks post surgery)
- Pain Questionnaires administered
- Lab tests (urine and 10cc of blood)
- Randomization into group 1 or 2
- Knee aspiration and administration of either 3ml of saline(placebo) or Hyaluronan (study drug)
Visit 4 (4-6 weeks post surgery)
- Pain Questionnaire administered
- Knee aspiration and lab specimens collected
- Patient reported outcomes (PROs) administered
Visit 5 (6 months follow-up/Early Termination Visit)
- Patient reported outcomes (PROs) administered
- Pain Questionnaires administered
- Functional laboratory testing
Visit 6 (12 months follow-up/Early Termination Visit)
- Patient reported outcomes (PROs) administered
- Pain Questionnaires administered
- Functional laboratory testing
- MRI scan
There are no costs associated with either the study medications and study-specific laboratory and imaging analyses. Either the participant or their insurance company, Medicare or Medicaid will be responsible for the costs of all care and treatment a participant receives during this study that they would normally receive for their condition. These are costs that are considered medically reasonable and necessary and will be part of the care a patient would receive if they did not take part in this study.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- Gel-One, Saline Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel-OneDrug
an injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery
Saline PlaceboOther
a placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Gel-One | Experimental | Gel-One (3ml/30 mg Hyaluronan) one time injection at visit 3 Receives: Drug: Gel-One |
| Group 1 - Saline Placebo | Placebo comparator | 3 ml saline placebo one time injection at visit 3 Receives: Other: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KOOS score over time
Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms
Measured: 12 months
Secondary outcomes (1)
Change in CTX-II pre and post surgery
CTX -II ELISA measurements
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start6 Apr 2017
- Primary completion23 Jun 2019
- Study completion23 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cale Jacobs, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cale Jacobs, PhD, University of Kentucky
- Investigators
- Cale Jacobs, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429140
- Sponsor's protocol ID
- 16-0662-F6A
- Acronym
- HEALR
- Status last verified
- Sep 2022
- First submitted
- 6 Feb 2017
- Last updated
- 13 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions
- ClinicalTrials.gov ID
- NCT03429140
- Acronym / sponsor ID
- HEALR / 16-0662-F6A
- Conditions
- Anterior Cruciate Ligament
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cale Jacobs, PhDUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 23 Jun 2019 (actual)
- Study completion
- 23 Jun 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- 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.
This research study is designed to allow the investigator to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis.
The purpose of this research is to gather information on how safe and effective Gel-One is in alleviating knee pain following ACL surgery.
Detailed description
This is a single-center, placebo-controlled, double-blinded, randomized controlled trial.
This trial will be conducted at the University of Kentucky's Orthopaedic and Sports Medicine Center (Turfland Facility), with subjects being recruited from the patient populations of UK's Sports Medicine surgeons (Drs. Christian Lattermann, Darren Johnson, Mary Lloyd Ireland, and Scott Mair) during regularly schedule office visits.
After providing informed consent, subjects will be randomized into one of two groups, and there will be 19 subjects per group. All groups will receive standard of care aspiration and triamcinolone injection (40mg, Kenalog) within 1-10 days after ACL injury. The subjects will undergo initial standard of care pre-habilitation as deemed necessary by the surgeon and will undergo ACL reconstruction surgery. Knee aspiration will be performed 7-10 days after ACL reconstruction surgery and the patients will be randomized into 1 of 2 groups:
- Group 1: will receive injection of Gel-One (3ml 30mg Hyaluronan)
- Group 2: will receive an injection of 3ml of a saline placebo
Knee Aspiration: All subjects will undergo a total of four aspirations.
Visit Schedule and Procedures:
Visit 1 Screening (1-10 days post injury): Upon arriving at the clinic potential subjects will have the following assessments: range of motion, knee instability (Lachman's test) and standardized Flexion weight bearing x-rays, all of which are the standard of care for a patient with a suspected ACL injury. After providing informed consent to participate in the study, subjects will be asked to fill in standard questionnaires.
Collection of urine and 10 cc of blood for laboratory testing, partial Medical history, concomitant medications, demographic information, body mass index (BMI) measurement, smoking status, and questions will be collected. Scheduling for study-related magnet resonance imaging (MRI) scans.
Visit 2 (day of surgery)
- Lab specimens collected (urine and 10cc of blood)
- Pain Questionnaires administered prior to surgery
- Knee aspiration (in the operating room under anesthesia, both knees)
- Patient reported outcomes (PROs) administered prior to surgery
Visit 3 (1-2 weeks post surgery)
- Pain Questionnaires administered
- Lab tests (urine and 10cc of blood)
- Randomization into group 1 or 2
- Knee aspiration and administration of either 3ml of saline(placebo) or Hyaluronan (study drug)
Visit 4 (4-6 weeks post surgery)
- Pain Questionnaire administered
- Knee aspiration and lab specimens collected
- Patient reported outcomes (PROs) administered
Visit 5 (6 months follow-up/Early Termination Visit)
- Patient reported outcomes (PROs) administered
- Pain Questionnaires administered
- Functional laboratory testing
Visit 6 (12 months follow-up/Early Termination Visit)
- Patient reported outcomes (PROs) administered
- Pain Questionnaires administered
- Functional laboratory testing
- MRI scan
There are no costs associated with either the study medications and study-specific laboratory and imaging analyses. Either the participant or their insurance company, Medicare or Medicaid will be responsible for the costs of all care and treatment a participant receives during this study that they would normally receive for their condition. These are costs that are considered medically reasonable and necessary and will be part of the care a patient would receive if they did not take part in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Gel-One | Experimental | Drug: Gel-OneGel-One (3ml/30 mg Hyaluronan) one time injection at visit 3 |
| Group 1 - Saline Placebo | Placebo comparator | Other: Saline Placebo3 ml saline placebo one time injection at visit 3 |
Who may qualify
- Ages
- 14 to 33 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 14-33 years of age
- Currently participating in a sporting activity
- ACL injury occurred while playing in a sporting activity
- Normal contralateral knee status
- Documentation of closed growth plates as noted on the screening x-rays
Key exclusion criteria (10 listed)
- Underlying inflammatory disease (i.e. Rheumatoid Arthritis, Psoriatic Arthritis etc)
- Currently have any infections, including infection of the skin, or have signs and symptoms of an infection, including fever
- Have a disease that weakens your immune system such as diabetes, cancer, HIV or AIDs
- Other major medical condition requiring treatment with immunosuppressant or modulating drugs
- A history of chronic use of non-steroidal anti-inflammatory drugs
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 |
|---|---|---|
| Gel-Onean injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery | Drug | Group 1 - Gel-One |
| Saline Placeboa placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery | Other | Group 1 - Saline Placebo |
Primary outcome
Change in KOOS score over time
Time frame: 12 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms
1 secondary outcome
Change in CTX-II pre and post surgery
Time frame: up to 4 weeks
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 13 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
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
Interventions to Enhance Quadriceps Output After ACLR
ACL
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
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.
Cale Jacobs, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gel-One in people with Anterior Cruciate Ligament, run by Cale Jacobs, PhD at 1 site in United States.
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 10 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Change in KOOS score over time (time frame: 12 months). 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 13 Sep 2022.