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Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

Primary Purpose

Olecranon Fracture

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Suture fixation
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Olecranon Fracture

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Sygehus - FarsøRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

K-wire tension band wiring

Suture fixation

Arm Description

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

The fracture is reduced and fixed with 2.0 Orthocord suture.

Outcomes

Primary Outcome Measures

Re-operation
The rate of re-operation

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2019
Last Updated
December 5, 2019
Sponsor
Aalborg University Hospital
Collaborators
Regionshospitalet Horsens, Aarhus University Hospital, Regionshospitalet Viborg, Skive, Kolding Sygehus, Randers Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04189185
Brief Title
Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
Official Title
Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Anticipated)
Primary Completion Date
November 20, 2021 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Regionshospitalet Horsens, Aarhus University Hospital, Regionshospitalet Viborg, Skive, Kolding Sygehus, Randers Regional Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Olecranon Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two study arms. One arm is treated with k-wire tension band wiring and one leg is treated with suture fixation
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
K-wire tension band wiring
Arm Type
Active Comparator
Arm Description
The patient is treated with 1.6 mm k-wires and 1 mm cerclage
Arm Title
Suture fixation
Arm Type
Active Comparator
Arm Description
The fracture is reduced and fixed with 2.0 Orthocord suture.
Intervention Type
Procedure
Intervention Name(s)
Suture fixation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Re-operation
Description
The rate of re-operation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Disabilities of the Arm, Shoulder and Hand (DASH) Score
Description
Patient reported outcome measure. Range from 0 (No disability) to 100 (most severe disability).
Time Frame
1 year
Title
European Quality of life - 5 Dimensions (EQ-5D) questionnaire
Description
Patient reported outcome measure. Score from 1 (best) to 3 (worst) in 5 different categories.
Time Frame
1 year
Title
Range of motion
Description
Range of motion in elbow
Time Frame
1 year
Title
Sick days
Description
Number of sick days/Return to work
Time Frame
1 year
Title
Non-union
Description
Rate of non-union
Time Frame
6 months
Title
Rate of complications
Description
Rate of complications to the treatment: Infection, nerve damage, delayed wound healing.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Qvist, MD
Phone
+45 9764 3000
Email
andreas.christensen@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Christensen, MD, PhD
Phone
+4522449180
Email
bjornbc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Qvist, MD
Organizational Affiliation
Aalborg University Hostipital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andreas Haubjerg Qvist, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Sygehus - Farsø
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Qvist, MD
Phone
+45 9764 3000
Email
andreas.christensen@rn.dk
First Name & Middle Initial & Last Name & Degree
Bjørn Christensen, MD, PhD
Phone
+4522449180
Email
bjornbc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Suture Fixation Versus Tension Band Wiring of Simple Displaced Olecranon Fractures

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