Weber B Ankle Fractures With Associated Posterior Malleolus Fracture

NCT05413707 | Recruiting DMC

• 1 other identifier: 255548
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posterior Malleolus Fractures; Ankle Fractures; Syndesmotic Injuries; Patient Reported Outcome Measure; Treatment Outcome

Keywords

Posterior malleolus fractures; Ankle factures; Weber B fractures; Syndesmotic injuries; Fixation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• EQ-5D 5L

  Baseline, 12 weeks, 1 year, 2 years and 5 years postoperatively

• VAS of stiffness (0-100)

  12 weeks, 1 year, 2 years and 5 years postoperatively

• Osteoarthritis

  2 years and 5 years postoperatively

• Dorsiflexion

  6 weeks, 12 weeks, 2 years postoperatively

• Change in Self-reported Foot and Ankle Score (SEFAS)

  Baseline, 12 weeks, 1 year, and 5 years postoperatively

Other Outcomes (1)

• Anchor questions for evaluation of prom

  Baseline (Generic health question). Alle questions: 3 months, 1 year, 2 years and 5 years postoperatively

Study Arms (2)

Fixation group

EXPERIMENTAL

Patients are placed in a prone position on the operating table. Fixation of the posterior malleolus fracture. Posterior, and/or lateral and medial malleolus fractures will be treated with open reduction and internal fixation. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. The posteromedial fragment in Mason and Molloy type 2B will be fixed with one or more screws, or plate, if this fragment is displaced more than 2 mm. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced \>2 mm depending on size and comminution of the fragment. The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suture button.

Procedure: Fixation of the posterior malleolus fractures; Procedure: Fixation of lateral and/or medial malleolus fractures; Procedure: Syndesmotic fixation

Non-fixation group

ACTIVE COMPARATOR

Patients are placed in a supine position on the operating table. No fixation of the PMF. The PMF is reduced by ligamentotaxis. Lateral and/or medial malleolus fractures will be treated with ORIF if present. ORIF of the posteromedial fragment in Mason and Molloy type 2B with one or more screws, or plate, if it is displaced more than 2 mm. Deltoid ligament injuries are repaired if incarcerated between medial malleolus and talus. A Tillaux-Chaput or Wagstaffe fragment is fixed with suture anchor, plate, screw or pin if displaced \>2 mm depending on size and comminution of the fragment. The syndesmosis is tested under fluoroscopy by lateralizing and then externally rotating the talus. If unstable it is fixed with one or two 3.5 mm cortical screws or a suturebutton.

Procedure: Fixation of lateral and/or medial malleolus fractures; Procedure: Syndesmotic fixation

Interventions

Fixation of the posterior malleolus fractures PROCEDURE

Fixation of the posterior malleolus fracture with screws and or plating.

Fixation group

Fixation of lateral and/or medial malleolus fractures PROCEDURE

Fixation with screws and/or plating

Fixation group; Non-fixation group

Syndesmotic fixation PROCEDURE

Fixation of unstable syndesmosis with one or two 3.5 mm tricortical screws, or with a suture button.

Fixation group; Non-fixation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Measurements are performed 5 millimeters (mm) cranial to the tibia plafond
• Posterior malleolus fractures involving less than 40% of the fibular notch are included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University Hospital, Akershus: collaborator
• Ullevaal University Hospital: collaborator
• Helse Stavanger HF: collaborator
• Alesund Hospital: collaborator
• Ostfold Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Helgeland Hospital Trust: collaborator

Study Sites (1)

Haukeland University Hospital, Orthopedic department

Bergen, Vestland, 5021, Norway

RECRUITING

Related Publications (28)

• 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.

  PMID: 25708027 BACKGROUND

• 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.

  PMID: 33203272 BACKGROUND

• 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.

  PMID: 30035614 BACKGROUND

• 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.

  PMID: 20444447 BACKGROUND

• 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.

  PMID: 31334465 BACKGROUND

• 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.

  PMID: 21353996 BACKGROUND

• 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.

  PMID: 30233966 BACKGROUND

• 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.

  PMID: 32086138 BACKGROUND

• 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.

  PMID: 21245717 BACKGROUND

• 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.

  PMID: 27235525 BACKGROUND

• 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.

  PMID: 19798540 BACKGROUND

• 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.

  PMID: 16467626 BACKGROUND

• 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.

  PMID: 29887634 BACKGROUND

• 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.

  PMID: 21108526 BACKGROUND

• 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.

  PMID: 31390895 BACKGROUND

• 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.

  PMID: 19356354 BACKGROUND

• 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.

  PMID: 24252973 BACKGROUND

• 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.

  PMID: 20182256 BACKGROUND

• 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.

  PMID: 15566703 BACKGROUND

• 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.

  PMID: 23447507 BACKGROUND

• 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.

  PMID: 28758439 BACKGROUND

• 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.

  PMID: 26253385 BACKGROUND

• 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.

  PMID: 33580301 BACKGROUND

• 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.

  PMID: 33751133 BACKGROUND

• 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.

  PMID: 33446454 BACKGROUND

• B.G., Weber VHHB. Classification of ankle fractures. Die Verletzungen des oberen Sprung-gelenkes. 1972;(2nd ed.).

  BACKGROUND

• 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.

  PMID: 28867644 BACKGROUND

• 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.

  PMID: 30709682 BACKGROUND

MeSH Terms

Conditions

Ankle Fractures; Ankle Injuries

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Jonas M Fevang, PhD

  Helse Bergen, Haukeland University Hospital

  STUDY DIRECTOR

• Jostein S Nilsen, MD

  Helse Bergen, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

• Kristian Pilskog, MD

  Helse Bergen, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jostein S Nilsen, MD

CONTACT

004792226426; jostein.skorpa.nilsen@helse-bergen.no

Kristian Pilskog, MD

CONTACT

+4798217343; kpilskog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with to arms: Fixation of posterior malleolus fractures (PMFs) versus no fixation of the PMF.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 10, 2022
• Study Start: March 13, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)