To investigate the clinical efficacy of the Generation II (G II) knee brace, a newly developed knee orthosis, on patients experiencing severe medial compartment osteoarthritis (OA) of the knee.

Case series.

A national medical and pharmaceutical hospital in Japan.

Twenty primary OA subjects (excluding those with secondary OA), all older than 55 years of age and experiencing only knee joint problems, were selected according to their ability to walk more than 500 meters independent of support. These patients had arthritis in both knees and no less than one half of normal joint space remaining as revealed by roentgenogram studies. The more severely affected side was selected for bracing.

For 12 months, each patient wore a G II knee brace on the affected knee on a daily basis, removing it only at night. To evaluate the effects of G II OA brace alone, additional use of new oral drugs or any other treatment was prohibited from 1 month before application of the G II OA brace and throughout the trial period.

Clinical efficacy was evaluated using the Japan Orthopaedic Association's knee scoring system. X-ray evaluation was performed with patients standing on one leg. A dynamometer was used to evaluate isokinetic quadriceps muscle strength. The center of gravity was measured using an X-Y recording. Clinical evaluation was performed every 2 months thereafter. Final evaluation was at 12 months.

Nineteen of the 20 patients answered that they experienced significant pain relief. Knee pain scores on walking increased from 18.0 to 21.5 and on ascending and descending stairs increased from 12.8 to 15.8. The femorotibial angle decreased in 12 of the patients, and the mean angle decreased from 185.1 degrees before application to 183.7 degrees with the brace on at the final observation period. In addition, isokinetic quadriceps muscle strength increased from an average of 36.8 Nm to 42.8 Nm for all patients. In 17 patients, quadriceps muscle strength increased, while it decreased in 2 and remained the same in 1. Finally, lateral movement of the center of gravity decreased compared with before G II application in all patients.

G II bracing is a beneficial treatment for severe medial OA of the knee.

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