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Olecranon FractureNCT04189185

Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

A study testing Suture fixation in people with Olecranon Fracture, run by Aalborg University Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Olecranon Fracture
What is being tested?
Suture fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteDenmark
Study dates
5 Dec 2019to 20 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Olecranon fracture, Mayo Type 2A

Who cannot join

  • Bilateral upper extremity fracture
  • Open fracture
  • Neurovascular affection
  • Injury to ligament, dislocation or subluxation
  • Additional upper extremity fracture
  • Pathological fracture
Show all 11Show fewer
  • Previous elbow issue
  • Fracture more than 14 days old
  • Substance abuse
  • medical contraindication for surgery
  • Previous fracture to the same elbow

Trial locations and contacts

1 site in 1 country.

Andreas Qvist, MD contact

+45 9764 3000

andreas.christensen@rn.dk

Bjørn Christensen, MD, PhD contact

+4522449180

bjornbc@gmail.com

Denmark1 site, 1 recruiting

  • Aalborg Sygehus - Farsø

    Aalborg, 9000

    Andreas Qvist, MD, +45 9764 3000, andreas.christensen@rn.dk

    Bjørn Christensen, MD, PhD, +4522449180, bjornbc@gmail.com

    Recruiting

Other trials in Denmark

About this study

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.

Read the 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

Being tested
Suture fixation
Medical subject headings
Olecranon Fracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Suture fixationProcedure or surgery

    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.

Study groups in NCT04189185
Study groupRoleWhat they receive
K-wire tension band wiringActive comparatorThe patient is treated with 1.6 mm k-wires and 1 mm cerclage
Receives: Procedure: Suture fixation
Suture fixationActive comparatorThe fracture is reduced and fixed with 2.0 Orthocord suture.
Receives: Procedure: Suture fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Re-operation

    The rate of re-operation

    Measured: 1 year

Secondary outcomes (6)

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

    Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability).

    Measured: 1 year

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

    Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.

    Measured: 1 year

  3. Range of motion

    Range of motion in elbow

    Measured: 1 year

  4. Sick days

    Number of sick days/Return to work

    Measured: 1 year

  5. Non-union

    Rate of non-union

    Measured: 6 months

  6. Rate of complications

    Rate of complications to the treatment: Infection, nerve damage, delayed wound healing.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2019
  2. Study start5 Dec 2019 (estimated)
  3. Primary completion20 Nov 2021 (estimated)
  4. Study completion20 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04189185
Sponsor's protocol ID
20190039
Status last verified
Dec 2019
First submitted
19 Nov 2019
Last updated
6 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22077988

  • 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.

    PubMed 8666617

  • 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.

    PubMed 25426876

  • 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.

    PubMed 28763412

  • 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.

    PubMed 3440616

  • 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.

    PubMed 10982677

  • 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.

    PubMed 24893946

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

    PubMed 3908460

  • 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.

    PubMed 28932288

  • 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.

    PubMed 26630656

  • 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.

    PubMed 20937160

  • 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.

    PubMed 8773720

  • 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.

    PubMed 10109801

  • 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.

    PubMed 12809562

  • 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.

    PubMed 11861726

Questions about this trial

What is this clinical trial studying?

A study testing Suture fixation in people with Olecranon Fracture, run by Aalborg University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andreas Qvist, MD (+45 9764 3000, andreas.christensen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Re-operation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04189185, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.

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