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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00717171
Other study ID # S060501-ACL
Secondary ID
Status Terminated
Phase Phase 4
First received July 14, 2008
Last updated January 8, 2009
Start date July 2006
Est. completion date June 2009

Study information

Verified date January 2009
Source VQ OrthoCare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

- 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)

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
SurgiStim3
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.
SurgiStim3
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).

Locations

Country Name City State
United States Southern California Orthopedic Institute Van Nuys California

Sponsors (1)

Lead Sponsor Collaborator
VQ OrthoCare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary pain post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 No
Secondary pain medications post-op days 1, 3, 5, 7, 14, 21, 28, 35, 42 No
Secondary edema post-op days 7, 14, 21, 28, 35, 42 No
See also
  Status Clinical Trial Phase
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Completed NCT00492609 - Medical and Economical Evaluation of Computer-assisted Reconstruction of the Anterior Cruciate Ligament (ACL) N/A
Recruiting NCT05470790 - Arabic Version of Marx Activity Rating and Knee Stability in Sports/Cutting-Pivoting Ability Scales
Completed NCT01148784 - Comparison of Doubled Quadrupled Versus Quadrupled Allograft Tissue Constructs for Anterior Cruciate Ligament (ACL) Reconstruction N/A
Completed NCT01194505 - Ultrasound Guided Obturator Nerve Block for Anterior Cruciate Ligament Reconstruction (ACL) N/A
Active, not recruiting NCT00490594 - SeriACLâ„¢ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction Phase 1
Terminated NCT01919658 - Effects of Femoral vs Saphenous Nerve Blocks on Function After ACL Repair N/A
Recruiting NCT05799235 - Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents N/A
Completed NCT02895607 - Evaluation of Outpatient Surgery in the Anterior Cruciate Ligament Reconstructions With Hamstring Hospital
Completed NCT03429140 - Early Anti-inflammatory Treatment in Patients With Acute ACL Tear and Painful Effusions Early Phase 1