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Comparison of a Technique Using a New Percutaneous Osteosynthesis Device with Conventional Open Surgery for Displaced Patella Fractures in a Randomized Controlled Trial

Luna-Pizarro, Daniel MD, MSc*; Amato, Dante MD, PhD; Arellano, Francisco MD*,; Hernández, Armando MD*,; López-Rojas, Pablo MD, MSc

doi: 10.1097/01.bot.0000244994.67998.1b
Original Article
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Objective: To compare the percutaneous patellar osteosynthesis system (PPOS) technique with open surgery for patella fractures.

Design: Randomized controlled trial.

Setting: Referral orthopedic and trauma center.

Patients: Fifty-three patients with displaced patellar fractures.

Intervention: Stabilization and fixation of patellar fractures with PPOS or open surgery.

Main outcome measurements: Knee-flexion and -extension angles, pain, surgical time, and assessment of knee function based on the Knee Society Clinical Rating Scale (KSCRS).

Results: Comparison of PPOS and open-surgery groups at 4 weeks showed the following: pain, 3.7 ± 1.6 versus 6.2 ± 1.4 arbitrary units, P < 0.001; flexion angle, 46 ± 20.7 versus 12.7 ± 6.0 degrees, P < 0.001; extension angle, −2.5 versus −3.8 degrees, P < 0.001. At 8 weeks, the following was demonstrated: pain, 1.3 ± 1.6 versus 4.1 ± 2.1 arbitrary units, P < 0.001; flexion angle, 87 ± 17.3 versus 34 ± 26 degrees, P < 0.001; extension angle, 0 versus −3 degrees, P < 0.001. Surgical time was 35.3 ± 7.8 versus 66.2 ± 14.1 minutes, P < 0.001. KSCRS assessment was 84 ± 4 versus 70 ± 8, P < 0.001 at 8 weeks; 85 ± 2 versus 73 ± 8, P < 0.001 at 12 months; and 85 ± 1 versus 82 ± 7, P = 0.246 at 24 months. Frequency of total complications (infections, fragment displacement, and wire-related pain) was significantly lower in the PPOS than in the open-surgery group (P < 0.02).

Conclusions: PPOS for patella fractures was associated with shorter surgical time, less pain, better mobility angles, higher functional score up to 2 years, and a lower incidence of complications than open surgery.

Accepted for publication June 27, 2006.

From the *Department of Knee Joint Orthopedic and Traumatology Surgery, Hospital de Ortopedia “Dr. Victorio de la Fuente Narváez,” Instituto Mexicano del Seguro Social, Mexico City, Mexico; †Coordinación de Investigación en Salud, Instituto Mexicano del Seguro Social, Mexico City, Mexico; and ‡Coordinación de Salud en el Trabajo, Instituto Mexicano del Seguro Social, Mexico City, Mexico.

The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

The devices that are the subject of this manuscript are not FDA approved and are not commercially available in the United States of America.

The primary institution has approved the protocol involving human subjects in this work, and all experimentation was conducted in conformity with ethical and humane principles of research.

Reprints: Dr. Daniel Luna-Pizarro, Coatepec 4, Colonia Roma Sur, Delegación Cuauthémoc, Mexico City, D. F., CP 06760, Mexico (e-mail: daniello1965@hotmail.com).

© 2006 Lippincott Williams & Wilkins, Inc.