Randomzied Controlled Trial Comparing Tension Band Wiring and Plate Fixation in the Treatment of Olecranon Fractures in Adults

Operative Treatment of Olecranon Fractures



Sponsors


Source

Oslo University Hospital

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

The incidence of olecranon fractures is 12 per 100.000. Traditionally, isolated olecranon
fractures have been treated with tension band wiring (TBW). There is a trend towards
increased use of plate fixation, though TBW has yielded good and comparable patient reported
outcomes. The latter method is substantially cost-effective, but higher complication reports
have been reported. There are only two randomized controlled trials comparing TBW and plate
fixation, and the literature is inconclusive in which fixation method is preferable in the
treatment of olecranon fractures. In this multi-center trial, adult patients (18-75 years)
with isolated olecranon fractures will be randomized to either TBW or plate fixation.

Detailed Description

Introduction:

The incidence of proximal ulna fractures is 12 per 100.000, and 10 % of all fractures in the
upper extremity involve the olecranon. There are several systems classifying olecranon
fractures. One of the most frequently used is the Mayo classification system as described by
Cabanela and Morrey. Tension band wiring (TBW) is the most common operative technique for the
treatment of olecranon fractures, and is said to be the gold standard in the treatment of
non-comminuted and minimally comminuted displaced olecranon fractures. Treatment with TBW has
shown good clinical results, but due to the thin layer of tissue overlying the proximal ulna,
hardware issues are common. The frequency of hardware removal following TBW has been reported
as high as 82 %. Only two randomized trials have compared TBW and plate fixation of olecranon
fractures. Hume and Wiss compared TBW with one-third tubular plate fixation. The authors
found no significant functional differences between the treatment methods, but the rate of
symptomatic hardware problems was higher in the group treated with TBW. The authors also
noted that loss of reduction was higher in the TBW group at final follow-up (12 months after
surgery). Duckworth found no difference in patient reported outcome after one year. The
sophistication in plate fixation has evolved since Hume and Wiss published their 25 years
ago. The use of locking stable plate fixation in the treatment of olecranon fractures is
preferred by many surgeons, especially when treating osteoporotic individuals and in cases
with severe fracture fragmentation. Though locking stable implants have shown to improve
fragment fixation in biomechanical and cadaveric studies, better patient reported outcome in
clinical studies has yet to be proven. It is still unclear if all comminuted fractures should
be treated with plate fixation, or if moderately comminuted fractures can be treated with
TBW. Hardware related issues following plate fixation have also been described as a frequent
problem, and rates of hardware removal up to 56 % have been reported. When approaching the
issue of symptomatic hardware problems following TBW and plate fixation, one must take into
consideration that the magnitude of secondary surgery is different. The removal of the two
K-wires is less extensive than removing an angular stable plate fixation. Removal of
symptomatic pin protrusion can be achieved in local anesthesia at the outpatient clinic,
whereas plate removal routinely is done in the operating theatre, and usually requires that
patient is in regional or general anesthesia. Of course, if the wire cerclage has to be
removed in addition to the K-wires, the scope of the procedure is more comparable. There are
strong indications that locking plate fixation yield better results when treating severely
comminuted olecranon fractures, but the investigators do not know if these modern implants
are superior in the treatment of moderately comminuted fractures. Even so, there is a trend
toward treating all comminuted olecranon fractures with plate fixation, but the clinical
evidence supporting this is limited. The investigators believe there is a need for a robust
investigation in the treatment of olecranon fractures to identify the fracture patterns that
adequately can be treated with TBW and the ones that should be treated with locking plate
fixation.

Study aims:

The investigators want to compare an angular stable plate fixation with TBW in a randomized,
controlled multi-center trial. Our hypothesis is that TBW is non-inferior in the treatment of
Mayo type IIA and IIB fractures compared with an angular stable implant. The primary outcome
measure is the Disability of the Arm, Shoulder and Hand outcome measure (DASH) at 12 months

Study design and methodology:

The study is a randomized, controlled, multicenter trial. Adult patients (18-75 years)
admitted with a displaced olecranon fracture in need of surgery will be randomized to either
TBW or plate fixation. The design is semi-blinded. At follow-up, an independent investigator
will perform an interview and blinded functional examination, followed by an un-blinded
examination and interview. Patients will be recruited at the Oslo University Hospital, and
other hospitals in the region has been invited to participate in the trial. An experienced
trauma surgeon will verify that the fracture meets the inclusion criteria, and the patient
will be given thorough oral and written information. After signed consent, the randomization
allocation to treatment method will be performed by means of a web-solution made by NTNU
WebCRF system with the approval from the OUS Head of Patient Security. To secure an even
dispersion in regard to age of the patients and fracture pattern, the inclusion of study
patients will be stratified. This will achieve an equal randomization dispersion of patients
in in the age interval from 18 to 50 years, and 50 to 75 years. Comminuted and non-comminuted
fracture fractures will be randomized in the same fashion.

Power analysis and sample size:

Using the mean value of DASH following olecranon fracture in a similar population, the
investigators found the standard deviation (SD) to equal 12 points. The minimal clinical
important difference (MCID) has been set to 10 points, and the non-inferiority limit is DASH
reduction of 10 points. Level of significance (α) equals 0.05. To prove non-inferiority, a
power of 0.90 and with non-inferiority limit at 10, the number required in each group is 25
patients. Taking into account a predicted loss of patients during follow-up, the
investigators aim to include at least 28 patients in each group.

Follow-up:

The study patients will be followed-up over a one year period (6 weeks, 12 weeks, 12 months).
The rate of hardware removal in both groups will be recorded, and the indication for removal
(pain, skin protrusion/wound problems, nerve irritation etc.) will be registered and
categorized. All other reoperations will be recorded as well.

Overall Status

Not yet recruiting

Start Date

2017-10-15

Completion Date

2031-10-15

Primary Completion Date

2021-10-15

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

The Disability of the Arm, Shoulder and Hand Outcome Measure (DASH)
12 months

Secondary Outcome

Measure

Time Frame

Mayo Elbow Performance Score (MEPS)
12 months
Grip strength
12 months
Elbow flexion and extension strength
12 months
Range of motion (ROM)
12 months
The EuroQol five dimensions questionnaire (EQ-5D-5L)
12 months
Satisfaction with elbow function
12 months
Pain
12 months
Complications
12 months
Hardware removal
12 months
Radiographic evaluation
12 months

Enrollment

56

Condition


Intervention

Intervention Type

Procedure

Intervention Name


Description

2 x K-wire fixation (1.6 mm) and wire cerclage.

Arm Group Label

Tension band wiring (TBW)

Plate fixation



Intervention Type

Procedure

Intervention Name


Description

Olecranon fractures in this arm are fixed with Synthes´ VA-LCP Olecranon Plates 2.7/3.5.

Arm Group Label

Tension band wiring (TBW)

Plate fixation




Eligibility

Criteria

Inclusion Criteria:

- Patients between the age of 18 and 75 years with an olecranon fracture Mayo type IIA
or IIB will be eligible for inclusion.

Exclusion Criteria:

- Patients younger than 18 or older than 75 years of age.

- Unable to receive oral and written information.

- Concomitant fracture in the injured extremity.

- When the olecranon fracture extends distal to the coronoid process.

- Previous injury or illness in the injured upper extremity with permanent reduced elbow
function.

Gender

All

Minimum Age

18 Years

Maximum Age

75 Years

Healthy Volunteers

No


Overall Contact

Last Name

Kaare S Midtgaard, MD

Phone

+4793412696

Email



Location

Facility

Oslo University Hospital
Oslo Norway

Location Countries

Country

Norway


Verification Date

2017-09-01

Lastchanged Date

2017-09-11

Firstreceived Date

2017-09-09

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Oslo University Hospital

Investigator Full Name

Kaare Sourin Midtgaard

Investigator Title

Consultant orthopedic surgeon


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Tension band wiring (TBW)

Arm Group Type

Active Comparator

Description

TBW following the AO principles with 2 x 1.6 mm K-wires and wire wire cerclage.


Arm Group Label

Plate fixation

Arm Group Type

Active Comparator

Description

Plate fixation with Syntes VA-LCP olecranon plates 2.7/3.5



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Gunnar B Flugsrud, MD, PhD

Phone

+4792296626

Email



Reference

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.

PMID

28763412


Citation

Hume MC, Wiss DA. Olecranon fractures. A clinical and radiographic comparison of tension band wiring and plate fixation. Clin Orthop Relat Res. 1992 Dec;(285):229-35.

PMID

1446443


Citation

Buijze G, Kloen P. Clinical evaluation of locking compression plate fixation for comminuted olecranon fractures. J Bone Joint Surg Am. 2009 Oct;91(10):2416-20. doi: 10.2106/JBJS.H.01419.

PMID

19797577


Citation

Chalidis BE, Sachinis NC, Samoladas EP, Dimitriou CG, Pournaras JD. Is tension band wiring technique the "gold standard" for the treatment of olecranon fractures? A long term functional outcome study. J Orthop Surg Res. 2008 Feb 22;3:9. doi: 10.1186/1749-799X-3-9.

PMID

18294381


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.

PMID

22077988


Citation

Baecher N, Edwards S. Olecranon fractures. J Hand Surg Am. 2013 Mar;38(3):593-604. doi: 10.1016/j.jhsa.2012.12.036. Review.

PMID

23428192


Citation

Edwards SG, Martin BD, Fu RH, Gill JM, Nezhad MK, Orr JA, Ferrucci AM, Love JM, Booth R, Singer A, Hsieh AH. Comparison of olecranon plate fixation in osteoporotic bone: do current technologies and designs make a difference? J Orthop Trauma. 2011 May;25(5):306-11. doi: 10.1097/BOT.0b013e3181f22465.

PMID

21464739


Citation

Karlsson MK, Hasserius R, Karlsson C, Besjakov J, Josefsson PO. Fractures of the olecranon: a 15- to 25-year followup of 73 patients. Clin Orthop Relat Res. 2002 Oct;(403):205-12.

PMID

12360028


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.

PMID

25426876


Citation

Rommens PM, Küchle R, Schneider RU, Reuter M. Olecranon fractures in adults: factors influencing outcome. Injury. 2004 Nov;35(11):1149-57.

PMID

15488508


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.

PMID

24893946


Citation

Tarallo L, Mugnai R, Adani R, Capra F, Zambianchi F, Catani F. Simple and comminuted displaced olecranon fractures: a clinical comparison between tension band wiring and plate fixation techniques. Arch Orthop Trauma Surg. 2014 Aug;134(8):1107-14. doi: 10.1007/s00402-014-2021-9. Epub 2014 Jun 17.

PMID

24935660


Citation

Wagner FC, Konstantinidis L, Hohloch N, Hohloch L, Suedkamp NP, Reising K. Biomechanical evaluation of two innovative locking implants for comminuted olecranon fractures under high-cycle loading conditions. Injury. 2015;46(6):985-9. doi: 10.1016/j.injury.2015.02.010. Epub 2015 Feb 18.

PMID

25771445


Citation

Gruszka D, Arand C, Nowak T, Dietz SO, Wagner D, Rommens P. Olecranon tension plating or olecranon tension band wiring? A comparative biomechanical study. Int Orthop. 2015 May;39(5):955-60. doi: 10.1007/s00264-015-2703-0. Epub 2015 Feb 25.

PMID

25711396


Citation

Wilson J, Bajwa A, Kamath V, Rangan A. Biomechanical comparison of interfragmentary compression in transverse fractures of the olecranon. J Bone Joint Surg Br. 2011 Feb;93(2):245-50. doi: 10.1302/0301-620X.93B2.24613.

PMID

21282766



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Single (Outcomes Assessor)

Masking Description

Semi-blinded



ClinicalTrials.gov processed this data on September 12, 2017

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