BACKGROUND: Retraction injury might explain the soft tissue complications seen after anterior cervical surgery. A novel retractor system (Seex retractor system [SRS]) that uses a principle of bone fixation with rotation has been shown to reduce retraction pressure in a cadaveric model of anterior cervical decompression and fusion. OBJECTIVE: To compare the conventional Cloward-style retractor (CRS) with the SRS in a prospective randomized clinical trial. METHODS: After ethics and study registration (ACTRN 12608000430336), eligible patients were randomized to either the CRS or SRS before 1- or 2-level anterior cervical decompression and fusion. The pressure beneath the medial retractor blade was recorded with a thin pressure transducer strip. Postoperative sore throat, dysphagia, and dysphonia were assessed after 1, 7, and 28 days. RESULTS:Twenty-six patients were randomized. There were no serious complications. Complication rates were low with a trend favoring SRS that was not statistically different. Average retraction pressure with SRS was 1.9 mm Hg and with CRS was 5.6 mm Hg (P < .001 on F test; P = .002 on 2-tailed t test). Mean average peak retraction pressure with the SRS was 3.4 mm Hg and with the CRS was 20 mm Hg (P < .001 on F test; P = .005 on 2-tailed t test). CONCLUSION: The new retractor is safe, and statistically similar complication rates were observed with the 2 systems. The SRS generated significantly less retraction pressure compared with the CRS. This difference can be explained by the different principles governing the function of these retractors. Bone fixation gives stability and rotation reduces tissue pressure, both desirable in a retractor.
RCT Entities:
BACKGROUND: Retraction injury might explain the soft tissue complications seen after anterior cervical surgery. A novel retractor system (Seex retractor system [SRS]) that uses a principle of bone fixation with rotation has been shown to reduce retraction pressure in a cadaveric model of anterior cervical decompression and fusion. OBJECTIVE: To compare the conventional Cloward-style retractor (CRS) with the SRS in a prospective randomized clinical trial. METHODS: After ethics and study registration (ACTRN 12608000430336), eligible patients were randomized to either the CRS or SRS before 1- or 2-level anterior cervical decompression and fusion. The pressure beneath the medial retractor blade was recorded with a thin pressure transducer strip. Postoperative sore throat, dysphagia, and dysphonia were assessed after 1, 7, and 28 days. RESULTS: Twenty-six patients were randomized. There were no serious complications. Complication rates were low with a trend favoring SRS that was not statistically different. Average retraction pressure with SRS was 1.9 mm Hg and with CRS was 5.6 mm Hg (P < .001 on F test; P = .002 on 2-tailed t test). Mean average peak retraction pressure with the SRS was 3.4 mm Hg and with the CRS was 20 mm Hg (P < .001 on F test; P = .005 on 2-tailed t test). CONCLUSION: The new retractor is safe, and statistically similar complication rates were observed with the 2 systems. The SRS generated significantly less retraction pressure compared with the CRS. This difference can be explained by the different principles governing the function of these retractors. Bone fixation gives stability and rotation reduces tissue pressure, both desirable in a retractor.