Recruiting

Phase 2

Torino IIUse of Pulsed Electromagnetic Fields for Postoperative Knee Pain

Sponsor:

Center for Joint Surgery and Sports Medicine, Maryland

Code:

NCT01415856

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Device (Torino II)

Sham Device (Torino II)

Study Details

Brief summary:

The purpose of this study is to determine whether the Torino II device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.

Conditions

Osteoarthritis

Study ID

NCT01415856

Start date

Oct, 2010

Status verified date

Aug, 2011

Primary completion date

May, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Age: greater than 18 years
Weight: less than 300 lbs.
Diagnosis: osteoarthritis
Type of Surgery: unilateral knee replacement

Exclusion Criteria:

No pacemaker or defibrillator.
No infection of the affected knee.
No previous open surgery of the affected knee.
No history of Rheumatoid Arthritis.
No more than 2 narcotic pills per month in the last 6 months for pain.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Sham Device (Torino II)

Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.

active comparator: Active Device (Torino II)

Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.

Interventions

Active Device (Torino II)

Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.

Sham Device (Torino II)

Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.

Primary outcome measure

Pain [ Time Frame: 2 weeks ]
Edema (Swelling) [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Ralph T Salvagno, MD

301-665-4575 ralphs@hipknee.com

Locations

Center for Joint Surgery and Sports Medicine

Recruiting

Hagerstown, Maryland, United States, 21742

Contacts

Ralph T Salvagno, MD

301-665-4575

More Information

Sponsor

Center for Joint Surgery and Sports Medicine, Maryland

Last update posted

Aug 12, 2011

Last verified

Aug, 2011

Keywords

pulsed electromagnetic fields device
Torino II
postoperative knee pain
knee replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Joint Surgery and Sports Medicine, Maryland on 2011-08-12.