Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
NCT ID: NCT04189185
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
88 participants
INTERVENTIONAL
2019-12-05
2023-11-20
Brief Summary
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Detailed Description
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The most common type is a simple two part fracture, Mayo type 2A, which represents 74% of all olecranon fractures. The typical treatment of Mayo type 2A fractures is osteosynthesis using k-wires and tension band wiring. This provides adequate fracture healing and good functional results. The use of plate osteosynthesis for Mayo type 2A fractures does not provide functional or health economic benefits compared with operation with tension band wiring.
Common for both techniques is a high risk of re-operation due to delayed healing of the surgical wound, and complications arising from the implanted material.
Recently, new techniques for Mayo type 2A fractures have been described, in which no metal is implanted. Osteosynthesis is achieved with strong sutures. These techniques have been shown to reduce the high risk of complications leading to re-operation without effecting the functional outcome or fracture healing rate.
Hypothesis The investigators hypothesize that suture fixation of Mayo type 2A fractures will decrease the risk of re-operation and provide equal functional outcome compared with tension band wiring.
Design Prospective, randomized multicenter study
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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K-wire tension band wiring
The patient is treated with 1.6 mm k-wires and 1 mm cerclage
Suture fixation
The fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration.
Suture fixation
The fracture is reduced and fixed with 2.0 Orthocord suture.
Suture fixation
The fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration.
Interventions
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Suture fixation
The fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Open fracture
* Neurovascular affection
* Injury to ligament, dislocation or subluxation
* Additional upper extremity fracture
* Pathological fracture
* Previous elbow issue
* Fracture more than 14 days old
* Substance abuse
* medical contraindication for surgery
* Previous fracture to the same elbow
18 Years
75 Years
ALL
No
Sponsors
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Regionshospitalet Horsens
OTHER
Aarhus University Hospital
OTHER
Regionshospitalet Viborg, Skive
OTHER
Kolding Sygehus
OTHER
Randers Regional Hospital
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Andreas Haubjerg Qvist
MD, Principal investigator
Principal Investigators
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Andreas Qvist, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hostipital
Andreas Haubjerg Qvist, MD
Role: PRINCIPAL_INVESTIGATOR
Aalborg University Hospital
Locations
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Aalborg Sygehus - Farsø
Aalborg, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Andreas Qvist, MD
Role: primary
Bjørn Christensen, MD, PhD
Role: backup
References
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Duckworth AD, Clement ND, Aitken SA, Court-Brown CM, McQueen MM. The epidemiology of fractures of the proximal ulna. Injury. 2012 Mar;43(3):343-6. doi: 10.1016/j.injury.2011.10.017. Epub 2011 Nov 9.
Ates Y, Atlihan D, Yildirim H. Current concepts in the treatment of fractures of the radial head, the olecranon and the coronoid. J Bone Joint Surg Am. 1996 Jun;78(6):969. No abstract available.
Matar HE, Ali AA, Buckley S, Garlick NI, Atkinson HD. Surgical interventions for treating fractures of the olecranon in adults. Cochrane Database Syst Rev. 2014 Nov 26;2014(11):CD010144. doi: 10.1002/14651858.CD010144.pub2.
Duckworth AD, Clement ND, White TO, Court-Brown CM, McQueen MM. Plate Versus Tension-Band Wire Fixation for Olecranon Fractures: A Prospective Randomized Trial. J Bone Joint Surg Am. 2017 Aug 2;99(15):1261-1273. doi: 10.2106/JBJS.16.00773.
Helm RH, Hornby R, Miller SW. The complications of surgical treatment of displaced fractures of the olecranon. Injury. 1987 Jan;18(1):48-50. doi: 10.1016/0020-1383(87)90386-x.
Romero JM, Miran A, Jensen CH. Complications and re-operation rate after tension-band wiring of olecranon fractures. J Orthop Sci. 2000;5(4):318-20. doi: 10.1007/s007760070036.
Snoddy MC, Lang MF, An TJ, Mitchell PM, Grantham WJ, Hooe BS, Kay HF, Bhatia R, Thakore RV, Evans JM, Obremskey WT, Sethi MK. Olecranon fractures: factors influencing re-operation. Int Orthop. 2014 Aug;38(8):1711-6. doi: 10.1007/s00264-014-2378-y. Epub 2014 Jun 4.
Macko D, Szabo RM. Complications of tension-band wiring of olecranon fractures. J Bone Joint Surg Am. 1985 Dec;67(9):1396-401.
Phadnis J, Watts AC. Tension band suture fixation for olecranon fractures. Shoulder Elbow. 2017 Oct;9(4):299-303. doi: 10.1177/1758573216687305. Epub 2017 Jan 18.
Das AK, Jariwala A, Watts AC. Suture Repair of Simple Transverse Olecranon Fractures and Chevron Olecranon Osteotomy. Tech Hand Up Extrem Surg. 2016 Mar;20(1):1-5. doi: 10.1097/BTH.0000000000000106.
Nimura A, Nakagawa T, Wakabayashi Y, Sekiya I, Okawa A, Muneta T. Repair of olecranon fractures using fiberWire without metallic implants: report of two cases. J Orthop Surg Res. 2010 Oct 12;5:73. doi: 10.1186/1749-799X-5-73.
Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996 Jun;29(6):602-8. doi: 10.1002/(SICI)1097-0274(199606)29:63.0.CO;2-L.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Gummesson C, Atroshi I, Ekdahl C. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: longitudinal construct validity and measuring self-rated health change after surgery. BMC Musculoskelet Disord. 2003 Jun 16;4:11. doi: 10.1186/1471-2474-4-11. Epub 2003 Jun 16.
Hunsaker FG, Cioffi DA, Amadio PC, Wright JG, Caughlin B. The American academy of orthopaedic surgeons outcomes instruments: normative values from the general population. J Bone Joint Surg Am. 2002 Feb;84(2):208-15. doi: 10.2106/00004623-200202000-00007.
Qvist AH, Christensen BB. Suture fixation versus tension band wiring in simple displaced olecranon fractures - a study protocol. Dan Med J. 2024 Oct 18;71(11):A01240038. doi: 10.61409/A01240038.
Other Identifiers
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20190039
Identifier Type: -
Identifier Source: org_study_id