Anterior Cruciate LigamentPhase 4NCT00717171
Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
A Phase 4 study testing SurgiStim3 in people with Anterior Cruciate Ligament, run by VQ OrthoCare at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anterior Cruciate Ligament
- What is being tested?
- SurgiStim3
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2009
- Phase
- Phase 4
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Agree to provide informed consent to be included within this ACL study
- Demonstrate a continued willingness to be compliant with the parameters established under the study;
- Have no history of drug or alcohol abuse in the last 2 years;
- Be either a male or female adult between the ages of 18 and 64;
- Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and
- Understand that there is no financial remuneration for participation in the study.
Who cannot join
- Pregnant women
- Insulin dependent diabetic patients
- Patients with a demand type pacemaker
- Patients who have a malignant tumor (other than basal cell epithelioma)
- Patients with a known history of alcohol or drug abuse in the last 2 years
- Patients who will not agree to provide informed consent to be included within this ACL study
Show all 15Show fewer
- Patients who demonstrate a continued unwillingness to be compliant with the parameters established under this study.
- "Poor healers" as identified by the patient's medical history
- Patients who have a history of sensitivity to surgical tape, electrode adhesives, etc.
- Patients with a known history of RSD (reflex sympathetic dystrophy)
- Patients with a history of chronic pain (on opiates or high dosage of NSAIDS for 3 months or greater)
- Patients who have previously undergone an ACL reconstruction on the same knee
- Patients with clinically varicose veins (clinically significant or symptomatic)
- Patients whose history shows an abuse of diuretics or anti-inflammatory medications
- Patients who will undergo multiple ligament surgery (i.e., ACL plus PCL, MCL, and/or LCL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Orthopedic Institute
Van Nuys, California, 91405
About this study
The purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.
- Conditions
- Anterior Cruciate Ligament
- Being tested
- SurgiStim3
- Keywords
- electrical stimulation, pain, medication, edema, interferential, neuromuscular, high voltage pulsed current, knee
- Medical subject headings
- Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgiStim3Device
Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42.
SurgiStim3Device
The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Device: SurgiStim3 |
| 2 | Experimental | Not described Receives: Device: SurgiStim3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Measured: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
Secondary outcomes (2)
pain medications
Measured: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
edema
Measured: post-op days 7, 14, 21, 28, 35, 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startJul 2006
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Why it stopped: Low enrollment
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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VQ OrthoCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark H Getelman, MD, Principal investigator, Southern California Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717171
- Sponsor's protocol ID
- S060501-ACL
- Status last verified
- Jan 2009
- First submitted
- 14 Jul 2008
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the SurgiStim3 Electrical Stimulation Device in Persons Undergoing Anterior Cruciate Ligament Repair
- ClinicalTrials.gov ID
- NCT00717171
- Acronym / sponsor ID
- S060501-ACL
- Conditions
- Anterior Cruciate Ligament
- Keywords
- electrical stimulation, pain, medication, edema, interferential, neuromuscular, high voltage pulsed current, knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VQ OrthoCareIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 16 Jul 2008 (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 purpose of this study is to determine whether a functional electrical stimulation device, the SurgiStim3, decreases pain, pain medications and/or edema in patients undergoing anterior cruciate ligament repair.
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 |
|---|---|---|
| 1 | Placebo comparator | Device: SurgiStim3 |
| 2 | Experimental | Device: SurgiStim3 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agree to provide informed consent to be included within this ACL study
- Demonstrate a continued willingness to be compliant with the parameters established under the study;
- Have no history of drug or alcohol abuse in the last 2 years;
- Be either a male or female adult between the ages of 18 and 64;
- Be undergoing a surgical repair of the anterior cruciate ligament (ACL) using either a hamstring, patella tendon, Achilles tendon, or allograft procedure; and
Key exclusion criteria (15 listed)
- Pregnant women
- Insulin dependent diabetic patients
- Patients with a demand type pacemaker
- Patients who have a malignant tumor (other than basal cell epithelioma)
- Patients with a known history of alcohol or drug abuse in the last 2 years
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 |
|---|---|---|
| SurgiStim3Electrical stimulation device that provides interferential, high voltage pulsed current and neuromuscular waveforms in sequence. The device runs continuously for the first 2 days following surgery, then runs 3 times a day for 1 hour on days 3 through 42. | Device | 2 |
| SurgiStim3The placebo device is programmed to run for the same amount of time, at the same schedule, using the same waveforms as the functional device over the course of the 42 days. The placebo device, however, will only increase to 80% of the patient-set amplitude after a one minute set-up period and will only turn on for 6 seconds of every minute (3s ramp up, 1s on time, 2s ramp down). | Device | 1 |
Primary outcome
pain
Time frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
2 secondary outcomes
pain medications
Time frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42
edema
Time frame: post-op days 7, 14, 21, 28, 35, 42
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
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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.
Mark H Getelman, MD principal investigator
Southern California Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SurgiStim3 in people with Anterior Cruciate Ligament, run by VQ OrthoCare 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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 12 Jan 2009. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
pain (time frame: post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42). 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 Jan 2009.