Ankle Fractures Clinical Trial
— PMFIXOfficial title:
Posterior Malleolus Fractures (PMF) in Weber B Ankle Fractures - Fixation Versus no Fixation - a Randomized Controlled Trial
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway. A posterior malleolar fragment (PMF), located on the lower backside of the tibia, is present in up to 46% of Weber B. Weber B fractures are the most common type of fractures of the fibula, located at the height of the syndesmosis. Patients with a PMF were recently shown to have significantly lower patient-reported outcome measures (PROM) than the general population. For this reason, the indication and choice of intervention for these fractures have been the object of increased interest over the recent years. It is one of the most debated areas within ankle fracture surgery. Traditionally, these PMFs have been treated with closed reduction, without direct manipulation of the PMF, anteroposterior screw fixation, or even no-fixation of the smaller fragments. A more novel posterior approach to the ankle for open reduction and internal fixation is increasingly popular and has led to fixation of smaller and medium-sized PMFs. Studies suggest fracture reduction is better with a posterior approach. However, there is no consensus as to what the best treatment is. There are no available randomized controlled studies examining PROM in patients after surgery with fixation versus no fixation for the PMF. Through a multicenter prospective randomized controlled trial initiated from Haukeland University Hospital, patients will be recruited and randomized to receive treatment with or without fixation of the PMF. Patients will be recruited at six study hospitals from all Regional Health Trusts in Norway. Treatment today is often based on local tradition and retrospective, ambiguous literature. As there is no clear evidence supporting the choice to fixate, or not fixate, the posterior malleolus fracture. The current study can contribute new knowledge and thereby contribute to an evidence-based approach to treating these patients. Mason and Molly type 2A and 2B fractures will be included in the study.
Status | Recruiting |
Enrollment | 198 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Posterior malleolar (PM) fracture, of Mason & Molly type 2A/2B, associated with Weber B lateral malleolar fracture, with or without medial malleolar fracture - Posterior malleoli >=2 mm displaced (on CT in axial, sagital or coronal plane) - Patients informed, written consent - Age 18-65 years - For inclusion axial CT images are examined - Measurements are performed 5 millimeters (mm) cranial to the tibia plafond - Posterior malleolus fractures involving less than 40% of the fibular notch are included. Exclusion Criteria: - Non-compliant patient, i.e.: dementia, alcohol- or substance abuse - ASA-4 patients - Known congenital bone decease - Pathological fractures - Immunocompromised patients - Tourists or patients on a short-term work/study permit - Previous injury or condition of the ipsilateral ankle or ipsilateral lower extremity with a resulting dysfunction - Poor controlled diabetes - Patients with known arterial insufficiency - Open fractures - Severely traumatized patients (ISS>16) - Patient declines to participate in study |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital, Orthopedic department | Bergen | Vestland |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital | Alesund Hospital, Helgelandssykehuset, Helse Stavanger HF, Ostfold Hospital Trust, St. Olavs Hospital, Ullevaal University Hospital, University Hospital, Akershus |
Norway,
Amorosa LF, Brown GD, Greisberg J. A surgical approach to posterior pilon fractures. J Orthop Trauma. 2010 Mar;24(3):188-93. doi: 10.1097/BOT.0b013e3181b91927. — View Citation
B.G., Weber VHHB. Classification of ankle fractures. Die Verletzungen des oberen Sprung-gelenkes. 1972;(2nd ed.).
Bartonicek J, Rammelt S, Kostlivy K, Vanecek V, Klika D, Tresl I. Anatomy and classification of the posterior tibial fragment in ankle fractures. Arch Orthop Trauma Surg. 2015 Apr;135(4):505-16. doi: 10.1007/s00402-015-2171-4. Epub 2015 Feb 24. — View Citation
Coster MC, Rosengren BE, Karlsson MK, Carlsson A. Age- and Gender-Specific Normative Values for the Self-Reported Foot and Ankle Score (SEFAS). Foot Ankle Int. 2018 Nov;39(11):1328-1334. doi: 10.1177/1071100718788499. Epub 2018 Jul 23. — View Citation
Fisher A, Bond A, Philpott MDG, Jayatilaka MLT, Lambert LA, Fisher L, Weigelt L, Myatt D, Molloy A, Mason L. The anatomy of the anterior inferior tibiofibular ligament and its relationship with the Wagstaffe fracture. Foot Ankle Surg. 2021 Apr;27(3):291-295. doi: 10.1016/j.fas.2021.01.003. Epub 2021 Jan 7. — View Citation
Forberger J, Sabandal PV, Dietrich M, Gralla J, Lattmann T, Platz A. Posterolateral approach to the displaced posterior malleolus: functional outcome and local morbidity. Foot Ankle Int. 2009 Apr;30(4):309-14. doi: 10.3113/FAI.2009.0309. — View Citation
Gandham S, Millward G, Molloy AP, Mason LW. Posterior malleolar fractures: A CT guided incision analysis. Foot (Edinb). 2020 Jun;43:101662. doi: 10.1016/j.foot.2019.101662. Epub 2019 Dec 30. — View Citation
Gardner MJ, Brodsky A, Briggs SM, Nielson JH, Lorich DG. Fixation of posterior malleolar fractures provides greater syndesmotic stability. Clin Orthop Relat Res. 2006 Jun;447:165-71. doi: 10.1097/01.blo.0000203489.21206.a9. — View Citation
Hermans JJ, Beumer A, de Jong TA, Kleinrensink GJ. Anatomy of the distal tibiofibular syndesmosis in adults: a pictorial essay with a multimodality approach. J Anat. 2010 Dec;217(6):633-45. doi: 10.1111/j.1469-7580.2010.01302.x. — View Citation
Hoogendoorn JM. Posterior Malleolar Open Reduction and Internal Fixation Through a Posterolateral Approach for Trimalleolar Fractures. JBJS Essent Surg Tech. 2017 Oct 25;7(4):e31. doi: 10.2106/JBJS.ST.17.00016. eCollection 2017 Dec 28. — View Citation
Jayatilaka MLT, Philpott MDG, Fisher A, Fisher L, Molloy A, Mason L. Anatomy of the Insertion of the Posterior Inferior Tibiofibular Ligament and the Posterior Malleolar Fracture. Foot Ankle Int. 2019 Nov;40(11):1319-1324. doi: 10.1177/1071100719865896. Epub 2019 Aug 8. — View Citation
Little MT, Berkes MB, Lazaro LE, Sculco PK, Helfet DL, Lorich DG. Complications following treatment of supination external rotation ankle fractures through the posterolateral approach. Foot Ankle Int. 2013 Apr;34(4):523-9. doi: 10.1177/1071100713477626. Epub 2013 Feb 27. — View Citation
Mason LW, Kaye A, Widnall J, Redfern J, Molloy A. Posterior Malleolar Ankle Fractures: An Effort at Improving Outcomes. JB JS Open Access. 2019 Jun 7;4(2):e0058. doi: 10.2106/JBJS.OA.18.00058. eCollection 2019 Apr-Jun. — View Citation
Mason LW, Marlow WJ, Widnall J, Molloy AP. Pathoanatomy and Associated Injuries of Posterior Malleolus Fracture of the Ankle. Foot Ankle Int. 2017 Nov;38(11):1229-1235. doi: 10.1177/1071100717719533. Epub 2017 Jul 31. — View Citation
McHale S, Williams M, Ball T. Retrospective cohort study of operatively treated ankle fractures involving the posterior malleolus. Foot Ankle Surg. 2020 Feb;26(2):138-145. doi: 10.1016/j.fas.2019.01.003. Epub 2019 Jan 18. — View Citation
Meijer DT, Doornberg JN, Sierevelt IN, Mallee WH, van Dijk CN, Kerkhoffs GM, Stufkens SA; Ankle Platform Study Collaborative - Science of Variation Group; Ankle Platform Study Collaborative - Science of Variation Group. Guesstimation of posterior malleolar fractures on lateral plain radiographs. Injury. 2015 Oct;46(10):2024-9. doi: 10.1016/j.injury.2015.07.019. Epub 2015 Jul 26. — View Citation
Metsemakers WJ, Morgenstern M, McNally MA, Moriarty TF, McFadyen I, Scarborough M, Athanasou NA, Ochsner PE, Kuehl R, Raschke M, Borens O, Xie Z, Velkes S, Hungerer S, Kates SL, Zalavras C, Giannoudis PV, Richards RG, Verhofstad MHJ. Fracture-related infection: A consensus on definition from an international expert group. Injury. 2018 Mar;49(3):505-510. doi: 10.1016/j.injury.2017.08.040. Epub 2017 Aug 24. — View Citation
Miller AN, Carroll EA, Parker RJ, Helfet DL, Lorich DG. Posterior malleolar stabilization of syndesmotic injuries is equivalent to screw fixation. Clin Orthop Relat Res. 2010 Apr;468(4):1129-35. doi: 10.1007/s11999-009-1111-4. Epub 2009 Oct 2. — View Citation
Mingo-Robinet J, Lopez-Duran L, Galeote JE, Martinez-Cervell C. Ankle fractures with posterior malleolar fragment: management and results. J Foot Ankle Surg. 2011 Mar-Apr;50(2):141-5. doi: 10.1053/j.jfas.2010.12.013. — View Citation
Ovaska MT, Makinen TJ, Madanat R, Kiljunen V, Lindahl J. A comprehensive analysis of patients with malreduced ankle fractures undergoing re-operation. Int Orthop. 2014 Jan;38(1):83-8. doi: 10.1007/s00264-013-2168-y. Epub 2013 Nov 20. — View Citation
Pilskog K, Gote TB, Odland HEJ, Fjeldsgaard KA, Dale H, Inderhaug E, Fevang JM. Traditional Approach vs Posterior Approach for Ankle Fractures Involving the Posterior Malleolus. Foot Ankle Int. 2021 Apr;42(4):389-399. doi: 10.1177/1071100720969431. Epub 2020 Nov 17. — View Citation
Rammelt S, Bartonicek J, Neumann AP, Kroker L. [Fractures of the anterolateral tibial rim : The fourth malleolus]. Unfallchirurg. 2021 Mar;124(3):212-221. doi: 10.1007/s00113-021-00959-y. Epub 2021 Feb 12. German. — View Citation
Rammelt S, Bartonicek J, Schepers T, Kroker L. Fixation of anterolateral distal tibial fractures: the anterior malleolus. Oper Orthop Traumatol. 2021 Apr;33(2):125-138. doi: 10.1007/s00064-021-00703-0. Epub 2021 Mar 22. — View Citation
Stufkens SA, van den Bekerom MP, Kerkhoffs GM, Hintermann B, van Dijk CN. Long-term outcome after 1822 operatively treated ankle fractures: a systematic review of the literature. Injury. 2011 Feb;42(2):119-27. doi: 10.1016/j.injury.2010.04.006. No abstract available. — View Citation
Tornetta P 3rd, Ricci W, Nork S, Collinge C, Steen B. The posterolateral approach to the tibia for displaced posterior malleolar injuries. J Orthop Trauma. 2011 Feb;25(2):123-6. doi: 10.1097/BOT.0b013e3181e47d29. — View Citation
Tosun B, Selek O, Gok U, Ceylan H. Posterior Malleolus Fractures in Trimalleolar Ankle Fractures: Malleolus versus Transyndesmal Fixation. Indian J Orthop. 2018 May-Jun;52(3):309-314. doi: 10.4103/ortho.IJOrtho_308_16. — View Citation
Verhage SM, Boot F, Schipper IB, Hoogendoorn JM. Open reduction and internal fixation of posterior malleolar fractures using the posterolateral approach. Bone Joint J. 2016 Jun;98-B(6):812-7. doi: 10.1302/0301-620X.98B6.36497. — View Citation
Weber M. Trimalleolar fractures with impaction of the posteromedial tibial plafond: implications for talar stability. Foot Ankle Int. 2004 Oct;25(10):716-27. doi: 10.1177/107110070402501005. — View Citation
* Note: There are 28 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Anchor questions for evaluation of prom | Generic and organ specific anchor questions for evaluation of SEFAS results and for patients satisfaction evaluation. | Baseline (Generic health question). Alle questions: 3 months, 1 year, 2 years and 5 years postoperatively | |
Primary | Self-Reported Foot and Ankle Score | Foot and ankle specific questionnaire with 12 questions with 5 levels. Total score from 0 (worst) to 48 (best). | 2 years postoperatively | |
Secondary | EQ-5D 5L | Generic patient reported outcome questionnaire, Presentation of both change from baseline to 12 weeks, 1 year, 2, years and 5 years postoperatively. Presentation of both EQ-5D-5L frequencies and proportions reported by dimension and level, EQ-5D VAS, and EQ-5D index score. | Baseline, 12 weeks, 1 year, 2 years and 5 years postoperatively | |
Secondary | VAS of stiffness (0-100) | Level of stiffness in the treated ankle from 0 (No stiffness) to 100 (No movement due to stiffness) | 12 weeks, 1 year, 2 years and 5 years postoperatively | |
Secondary | Osteoarthritis | Osteoarthritis on plain radiographs at 2- and 5-years postoperative graded by the Kellgren Lawrence classification | 2 years and 5 years postoperatively | |
Secondary | Dorsiflexion | - Dorsiflexion measured by goniometer
o With knee in flexion and the foot on the floor. The patient leans forward as far as possible without the heel lifting. The angle between the floor and the anterior boarder of the tibia is measured with a digital goniometer. |
6 weeks, 12 weeks, 2 years postoperatively | |
Secondary | Change in Self-reported Foot and Ankle Score (SEFAS) | Foot and ankle specific questionnaire with 12 questions with 5 levels. Total score from 0 (worst) to 48 (best). | Baseline, 12 weeks, 1 year, and 5 years postoperatively |
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