Journal of Orthopaedic Trauma Publish Ahead of Print DOI: 10.1097/BOT.0000000000000245
OTA Highlight Paper A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. Mélissa Laflamme, MD1, Etienne L. Belzile, MD2, Luc Bédard, MD3, Michel P. J. van den Bekerom, MD4, Mark Glazebrook, MD5, Stéphane Pelet, MD, Ph D3,6.
2
3
D
Department of Orthopaedic Surgery, CHU de Québec – Centre Hospitalier de l’Université Laval (CHUL), 2705, boul Laurier, Québec (Québec) Canada G1V 4G2 Department of Orthopaedic Surgery, CHU de Québec – L’Hôtel-Dieu de Québec, 11 Côte du Palais, Québec (Québec) Canada G1R 2J6
TE
1
Department of Orthopaedic Surgery, CHU de Québec – Hôpital Enfant-Jésus, 1401, 18èeme Rue, Québec (Québec) Canada G1J 1Z4 4
5
6
EP
Department of Orthopaedic Surgery, OLVG Oosterpark 9, 1090 HM Amsterdam The Netherlands
Department of Orthopedic Surgery, Dalhousie University - 1796 Summer St Halifax (Nova Scotia) B3H 3A7
Centre de recherche FRSQ du CHAUQ de Québec – Hôpital Enfant-Jésus, 1401, 18ème Rue, Québec (Québec) Canada G1J 1Z4
A
C C
Corresponding author: Stéphane Pelet, MD, PhD, FRCSC Orthopaedic surgeon Clinical Professor, Université Laval Centre de recherche FRSQ du Centre hospitalier affilié universitaire de Québec CHA-Pavillon Enfant-Jésus 1401, 18ème Rue, Québec (QC) G1J 1Z4 Tel : 418-649-0252 ext 3165 Fax : 418-649-5567 E-mail : [email protected] Running title : Ankle syndesmosis rupture and dynamic fixation
Conflict of interest statement and source of funding: S Pelet received an unrestricted grant from Arthrex Inc and all co-authors received a per patient enrollment fee. S.Pelet, M Laflamme, E Belzile and L Bedard are currently receiving institutional research support from DePuy Synthes, Stryker, MSSS and CIHR.E. Belzile is consultant for Zimmer. M Glazebrook is currently receiving institutional research support from Arthrex Inc.
Presented in part at the EFORT Annual Meeting, Istanbul, Turkey, June 8, 2013, and at the Annual Meeting of the Orthopaedic Trauma Association, Phoenix, Arizona, October 12, 2013.
Copyright Ó Lippincott Williams & Wilkins. All rights reserved.
[Texte]
C C
EP
TE
D
Structured abstract Objectives: To compare the clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw through four cortices) or a dynamic device (Tightrope, Arthrex, Naples, FL). Design: Multicenter randomized double-blind controlled trial. Settings: Study realised in five trauma centers (two Level 1 and 3 Level 2) in 2 countries. Patients/Participants: 70 subjects admitted for an acute ankle syndesmosis rupture entered the study and were randomized in two groups (dynamic fixation = 34, static fixation = 36). The two groups were similar regarding demographic, social and surgical data. 65 patients (dynamic = 33, static = 32) completed the study and were available for analysis. Intervention: Syndesmosis fixation in the static group was realised with a four cortices 3,5 mm cortical screw (Synthes, West Chester, PA), and in the dynamic group with one Tightrope (Arthrex, Naples, FL). Standardised rehabilitation process for the two groups: no weight-bearing in a cast for 6 weeks, then rehabilitation without protection. Main outcome measurement: Olerud-Molander score. Results: Subjects with dynamic fixation achieved better clinical performances as described with the OlerudMolander scores at three (68.8 vs 60.2, p=0,067), six (84.2 vs 76.8, p=0,082), and twelve months (93.3 vs 87.6, p=0,046). We also observed higher AOFAS scores at three months (78.6 vs 70.6, p=0,016), but THESE WERE not significant at six (87.1 vs 83.8, p=0,26) OR twelve months (93.1 vs 89.9, p=0,26). Implant failure was higher in the screw group (36.1% vs 0%, p
OTA Highlight Paper A prospective randomized multicenter trial comparing clinical outcomes of patients treated surgically with a static or dynamic implant for acute ankle syndesmosis rupture. Mélissa Laflamme, MD1, Etienne L. Belzile, MD2, Luc Bédard, MD3, Michel P. J. van den Bekerom, MD4, Mark Glazebrook, MD5, Stéphane Pelet, MD, Ph D3,6.
2
3
D
Department of Orthopaedic Surgery, CHU de Québec – Centre Hospitalier de l’Université Laval (CHUL), 2705, boul Laurier, Québec (Québec) Canada G1V 4G2 Department of Orthopaedic Surgery, CHU de Québec – L’Hôtel-Dieu de Québec, 11 Côte du Palais, Québec (Québec) Canada G1R 2J6
TE
1
Department of Orthopaedic Surgery, CHU de Québec – Hôpital Enfant-Jésus, 1401, 18èeme Rue, Québec (Québec) Canada G1J 1Z4 4
5
6
EP
Department of Orthopaedic Surgery, OLVG Oosterpark 9, 1090 HM Amsterdam The Netherlands
Department of Orthopedic Surgery, Dalhousie University - 1796 Summer St Halifax (Nova Scotia) B3H 3A7
Centre de recherche FRSQ du CHAUQ de Québec – Hôpital Enfant-Jésus, 1401, 18ème Rue, Québec (Québec) Canada G1J 1Z4
A
C C
Corresponding author: Stéphane Pelet, MD, PhD, FRCSC Orthopaedic surgeon Clinical Professor, Université Laval Centre de recherche FRSQ du Centre hospitalier affilié universitaire de Québec CHA-Pavillon Enfant-Jésus 1401, 18ème Rue, Québec (QC) G1J 1Z4 Tel : 418-649-0252 ext 3165 Fax : 418-649-5567 E-mail : [email protected] Running title : Ankle syndesmosis rupture and dynamic fixation
Conflict of interest statement and source of funding: S Pelet received an unrestricted grant from Arthrex Inc and all co-authors received a per patient enrollment fee. S.Pelet, M Laflamme, E Belzile and L Bedard are currently receiving institutional research support from DePuy Synthes, Stryker, MSSS and CIHR.E. Belzile is consultant for Zimmer. M Glazebrook is currently receiving institutional research support from Arthrex Inc.
Presented in part at the EFORT Annual Meeting, Istanbul, Turkey, June 8, 2013, and at the Annual Meeting of the Orthopaedic Trauma Association, Phoenix, Arizona, October 12, 2013.
Copyright Ó Lippincott Williams & Wilkins. All rights reserved.
[Texte]
C C
EP
TE
D
Structured abstract Objectives: To compare the clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5mm metallic screw through four cortices) or a dynamic device (Tightrope, Arthrex, Naples, FL). Design: Multicenter randomized double-blind controlled trial. Settings: Study realised in five trauma centers (two Level 1 and 3 Level 2) in 2 countries. Patients/Participants: 70 subjects admitted for an acute ankle syndesmosis rupture entered the study and were randomized in two groups (dynamic fixation = 34, static fixation = 36). The two groups were similar regarding demographic, social and surgical data. 65 patients (dynamic = 33, static = 32) completed the study and were available for analysis. Intervention: Syndesmosis fixation in the static group was realised with a four cortices 3,5 mm cortical screw (Synthes, West Chester, PA), and in the dynamic group with one Tightrope (Arthrex, Naples, FL). Standardised rehabilitation process for the two groups: no weight-bearing in a cast for 6 weeks, then rehabilitation without protection. Main outcome measurement: Olerud-Molander score. Results: Subjects with dynamic fixation achieved better clinical performances as described with the OlerudMolander scores at three (68.8 vs 60.2, p=0,067), six (84.2 vs 76.8, p=0,082), and twelve months (93.3 vs 87.6, p=0,046). We also observed higher AOFAS scores at three months (78.6 vs 70.6, p=0,016), but THESE WERE not significant at six (87.1 vs 83.8, p=0,26) OR twelve months (93.1 vs 89.9, p=0,26). Implant failure was higher in the screw group (36.1% vs 0%, p
