Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Simple displaced olecranon fractures are most often treated with tension band wiring. This is an effective treatment, but the risk of subsequent re-operation is high. The investigators propose open reduction and internal fixation with a strong suture, thus reducing the risk of re-operation significantly.

Study Overview

• Status: Recruiting
• Conditions: Olecranon Fracture
• Intervention / Treatment: Procedure: Suture fixation

Detailed Description

Background Olecranon fractures are frequent with an incidence of 11.5 per 100.000 people per year. Olecranon fractures are classified according to the Mayo classification in three groups. Type 1A and B are treated conservatively, while comminute fractures of type Mayo 2B and 3B are treated with plate osteosynthesis.

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

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Qvist, MD; Phone Number: +45 9764 3000; Email: andreas.christensen@rn.dk
• Study Contact Backup: Name: Bjørn Christensen, MD, PhD; Phone Number: +4522449180; Email: bjornbc@gmail.com

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg Sygehus - Farsø
    • Contact: Andreas Qvist, MD; Phone Number: +45 9764 3000; Email: andreas.christensen@rn.dk
    • Contact: Bjørn Christensen, MD, PhD; Phone Number: +4522449180; Email: bjornbc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Olecranon fracture, Mayo Type 2A

Exclusion Criteria:

• Bilateral upper extremity fracture
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: K-wire tension band wiring; The patient is treated with 1.6 mm k-wires and 1 mm cerclage	Procedure: 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.
Active Comparator: Suture fixation; The fracture is reduced and fixed with 2.0 Orthocord suture.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-operation	The rate of re-operation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Disabilities of the Arm, Shoulder and Hand (DASH) Score	Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability).	1 year
European Quality of life - 5 Dimensions (EQ-5D) questionnaire	Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.	1 year
Range of motion	Range of motion in elbow	1 year
Sick days	Number of sick days/Return to work	1 year
Non-union	Rate of non-union	6 months
Rate of complications	Rate of complications to the treatment: Infection, nerve damage, delayed wound healing.	1 year

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Aarhus University Hospital; Regionshospitalet Viborg, Skive; Regionshospitalet Horsens; Kolding Sygehus; Randers Regional Hospital
• Investigators: Principal Investigator: Andreas Qvist, MD, Aalborg University Hostipital; Principal Investigator: Andreas Haubjerg Qvist, MD, Aalborg University Hospital

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Am J Ind Med 1996 Sep;30(3):372.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 5, 2019
• Primary Completion (Anticipated): November 20, 2021
• Study Completion (Anticipated): November 20, 2023

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Ulna Fractures
• Other Study ID Numbers: 20190039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No