Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Olecranon Fracture Clinical Trial

Official title:

Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04189185
• Other study ID #: 20190039
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: November 20, 2023

Study information

• Verified date: December 2019
• Source: Aalborg University Hospital
• Contact: Andreas Qvist, MD
• Phone: +45 9764 3000
• Email: andreas.christensen[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Olecranon Fracture
• Ulna Fractures

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg Sygehus - Farsø	Aalborg

Sponsors (6)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aarhus University Hospital, Kolding Sygehus, Randers Regional Hospital, Regionshospitalet Horsens, Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. — View Citation

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. Epub 2003 Jun 16. — View Citation

Helm RH, Hornby R, Miller SW. The complications of surgical treatment of displaced fractures of the olecranon. Injury. 1987 Jan;18(1):48-50. — View Citation

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. Erratum in: Am J Ind Med 1996 Sep;30(3):372. — View Citation

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. — View Citation

Macko D, Szabo RM. Complications of tension-band wiring of olecranon fractures. J Bone Joint Surg Am. 1985 Dec;67(9):1396-401. — View Citation

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;(11):CD010144. doi: 10.1002/14651858.CD010144.pub2. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-operation	The rate of re-operation	1 year
Secondary	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
Secondary	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
Secondary	Range of motion	Range of motion in elbow	1 year
Secondary	Sick days	Number of sick days/Return to work	1 year
Secondary	Non-union	Rate of non-union	6 months
Secondary	Rate of complications	Rate of complications to the treatment: Infection, nerve damage, delayed wound healing.	1 year