G M Marcheggiani Muccioli1, P Wykes, B Hundle, A Grassi, G Roatti, L Funk. 1. Laboratorio di Biomeccanica ed Innovazione Tecnologica - Istituto Ortopedico Rizzoli, University of Bologna, via di Barbiano, 1/10, 40100, Bologna, Italy, marcheggianimuccioli@me.com.
Abstract
PURPOSE: The purpose of this pilot study was to determine whether the use of a synovial fluid substitute (Viscoseal) after arthroscopic subacromial decompression (ASD) of the shoulder was safe (primary outcome) and effective in reducing the postsurgical pain on the day of surgery and the time from surgery to discharge (secondary outcomes), compared with patients undergoing standard ASD alone. METHODS:Forty-six patients with primary isolated shoulder subacromial impingement were randomly assigned to either undergo SAD alone (control group: n = 21) or to receive 10 ml Viscoseal into the subacromial space at the end of the procedure (treatment group: n = 25). RESULTS: No adverse events were reported in either group. All clinical scores improved significantly in each group from preoperative to 12-week follow-up (p < 0.01). The Viscoseal group experienced significantly (p = 0.001) less severe pain 4 h after the surgery {mean 54.0 ± 43.1, median 50 [interquartile range (IQR) 0-100]} and shorter time from surgery to discharge [mean 5.2 ± 1.4, median 5 (IQR 4-6)] than the control group [mean 102.4 ± 40.2, median 100 (IQR 50-150) and mean 11.0 ± 5.3, median 12 (IQR 6-16), respectively]. The Viscoseal group also required less analgesia postoperatively than the control group in the first 8 h: 24% of the Viscoseal required no analgesia, while all patients in the control group required analgesia; 24% of the control group required opiates compared with 4% in the Viscoseal group. CONCLUSION:Viscoseal was safe and well tolerated after shoulder arthroscopy. It provided excellent pain relief and a faster discharge time after ASD of the shoulder. The use of Viscoseal should be investigated in larger randomized controlled trials and for other shoulder arthroscopy procedures. LEVEL OF EVIDENCE: Level II, Pilot Prospective Comparative Study.
RCT Entities:
PURPOSE: The purpose of this pilot study was to determine whether the use of a synovial fluid substitute (Viscoseal) after arthroscopic subacromial decompression (ASD) of the shoulder was safe (primary outcome) and effective in reducing the postsurgical pain on the day of surgery and the time from surgery to discharge (secondary outcomes), compared with patients undergoing standard ASD alone. METHODS: Forty-six patients with primary isolated shoulder subacromial impingement were randomly assigned to either undergo SAD alone (control group: n = 21) or to receive 10 ml Viscoseal into the subacromial space at the end of the procedure (treatment group: n = 25). RESULTS: No adverse events were reported in either group. All clinical scores improved significantly in each group from preoperative to 12-week follow-up (p < 0.01). The Viscoseal group experienced significantly (p = 0.001) less severe pain 4 h after the surgery {mean 54.0 ± 43.1, median 50 [interquartile range (IQR) 0-100]} and shorter time from surgery to discharge [mean 5.2 ± 1.4, median 5 (IQR 4-6)] than the control group [mean 102.4 ± 40.2, median 100 (IQR 50-150) and mean 11.0 ± 5.3, median 12 (IQR 6-16), respectively]. The Viscoseal group also required less analgesia postoperatively than the control group in the first 8 h: 24% of the Viscoseal required no analgesia, while all patients in the control group required analgesia; 24% of the control group required opiates compared with 4% in the Viscoseal group. CONCLUSION: Viscoseal was safe and well tolerated after shoulder arthroscopy. It provided excellent pain relief and a faster discharge time after ASD of the shoulder. The use of Viscoseal should be investigated in larger randomized controlled trials and for other shoulder arthroscopy procedures. LEVEL OF EVIDENCE: Level II, Pilot Prospective Comparative Study.
Authors: Nadja Saupe; Christian W A Pfirrmann; Marius R Schmid; Bernhard Jost; Clément M L Werner; Marco Zanetti Journal: AJR Am J Roentgenol Date: 2006-08 Impact factor: 3.959