Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial
Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical...
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BMJ Publishing Group
2021-10-01
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| Series: | BMJ Surgery, Interventions, & Health Technologies |
| Online Access: | https://sit.bmj.com/content/3/1/e000098.full |
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| author | Pasi Ohtonen Tero Kortekangas Harri Pakarinen Simo Taimela Teppo Jarvinen Ristomatti Lehtola Hannu-Ville Leskelä Olli Savola |
| author_facet | Pasi Ohtonen Tero Kortekangas Harri Pakarinen Simo Taimela Teppo Jarvinen Ristomatti Lehtola Hannu-Ville Leskelä Olli Savola |
| author_sort | Pasi Ohtonen |
| collection | DOAJ |
| description | Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms. |
| format | Article |
| id | doaj-art-cb91c64ecefa45ea9877486b260f0e50 |
| institution | OA Journals |
| issn | 2631-4940 |
| language | English |
| publishDate | 2021-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Surgery, Interventions, & Health Technologies |
| spelling | doaj-art-cb91c64ecefa45ea9877486b260f0e502025-08-20T02:17:49ZengBMJ Publishing GroupBMJ Surgery, Interventions, & Health Technologies2631-49402021-10-013110.1136/bmjsit-2021-000098Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trialPasi Ohtonen0Tero Kortekangas1Harri Pakarinen2Simo Taimela3Teppo Jarvinen4Ristomatti Lehtola5Hannu-Ville Leskelä6Olli Savola7Department of Surgery, Oulu University Hospital, Oulu, FinlandDepartment of Orthopaedics and Traumatology, Oulu University Hospital, Oulu, FinlandDepartment of Orthopaedics and Traumatology, Oulu University Hospital, Oulu, FinlandFinnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandFinnish Centre for Evidence-Based Orthopaedics (FICEBO), Department of Orthopaedics and Traumatology, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandDepartment of Orthopaedics and Traumatology, Oulu University Hospital, Oulu, FinlandDepartment of Orthopaedics and Traumatology, Oulu University Hospital, Oulu, FinlandPohjola Hospital, Helsinki, FinlandRoughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.https://sit.bmj.com/content/3/1/e000098.full |
| spellingShingle | Pasi Ohtonen Tero Kortekangas Harri Pakarinen Simo Taimela Teppo Jarvinen Ristomatti Lehtola Hannu-Ville Leskelä Olli Savola Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial BMJ Surgery, Interventions, & Health Technologies |
| title | Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial |
| title_full | Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial |
| title_fullStr | Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial |
| title_full_unstemmed | Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial |
| title_short | Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial |
| title_sort | surgery versus non operative treatment for er stress unstable weber b unimalleolar fractures a study protocol for a prospective randomized non inferiority super fin trial |
| url | https://sit.bmj.com/content/3/1/e000098.full |
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