Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

NCT04189185 | Unknown DMC

• 1 other identifier: 20190039
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Olecranon Fracture

Outcome Measures

Primary Outcomes (1)

• Re-operation

  The rate of re-operation

  1 year

Secondary Outcomes (6)

• The Disabilities of the Arm, Shoulder and Hand (DASH) Score

  1 year

• European Quality of life - 5 Dimensions (EQ-5D) questionnaire

  1 year

• Range of motion

  1 year

• Sick days

  1 year

• Non-union

  6 months

Study Arms (2)

K-wire tension band wiring

ACTIVE COMPARATOR

The patient is treated with 1.6 mm k-wires and 1 mm cerclage

Procedure: Suture fixation

Suture fixation

ACTIVE COMPARATOR

The fracture is reduced and fixed with 2.0 Orthocord suture.

Procedure: Suture fixation

Interventions

Suture fixation PROCEDURE

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.

K-wire tension band wiring; Suture fixation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Olecranon fracture, Mayo Type 2A

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Regionshospitalet Horsens: collaborator
• Aarhus University Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• Kolding Sygehus: collaborator
• Randers Regional Hospital: collaborator

Study Sites (1)

Aalborg Sygehus - Farsø

Aalborg, 9000, Denmark

RECRUITING

Related Publications (16)

• 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.

  PMID: 22077988 BACKGROUND

• 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.

  PMID: 8666617 BACKGROUND

• 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.

  PMID: 25426876 BACKGROUND

• 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.

  PMID: 28763412 BACKGROUND

• 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.

  PMID: 3440616 BACKGROUND

• 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.

  PMID: 10982677 BACKGROUND

• 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.

  PMID: 24893946 BACKGROUND

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

  PMID: 3908460 BACKGROUND

• 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.

  PMID: 28932288 BACKGROUND

• 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.

  PMID: 26630656 BACKGROUND

• 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.

  PMID: 20937160 BACKGROUND

• 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.

  PMID: 8773720 BACKGROUND

• 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.

  PMID: 10109801 BACKGROUND

• 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.

  PMID: 12809562 BACKGROUND

• 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.

  PMID: 11861726 BACKGROUND

• 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.

  PMID: 39575943 DERIVED

MeSH Terms

Conditions

Olecranon Fracture

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Ulna Fractures; Forearm Injuries; Fractures, Bone

Study Officials

• Andreas Qvist, MD

  Aalborg University Hostipital

  PRINCIPAL INVESTIGATOR

• Andreas Haubjerg Qvist, MD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Qvist, MD

CONTACT

+45 9764 3000; andreas.christensen@rn.dk

Bjørn Christensen, MD, PhD

CONTACT

+4522449180; bjornbc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An envelope deciding the treatment modality is drawn while the patient is anesthetized. Post operative follow-up is performed by blinded assessors. The treatment will be revealed after one year, or if the patient is excluded from the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal investigator

Model Details: Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 6, 2019
• Study Start: December 5, 2019
• Primary Completion: November 20, 2021
• Study Completion: November 20, 2023
• Last Updated: December 6, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)