Scandinavian Olecranon Research in the Elderly

Turku University Hospital68 enrolled

Overview

This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Olecranon Fracture

Interventions

Tension band wiring or plate fixationPROCEDURE

Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name

Sling or a long-arm plasterBEHAVIORAL

Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.

Eligibility

Sex: ALLMin age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon * Age of patient is 75 years or over at the time of the injury Exclusion Criteria: * A delay more than 2 weeks after traumatic event to the day of intervention * Mayo type 3 fracture * Fracture continuation distal to coronoideus * Other acute fracture or nerve damage of the ipsilateral upper limb * Old fracture (\<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb * Open fracture * Pathological fracture * History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent * Patient's inability to understand written and spoken Finnish or Swedish or Danish * Patient's denial for participation or cognitive incapability to provide consent * Patient physically unfit for surgery

Locations (4)

Turku Central University Hospital

Turku, Southwest Finland, Finland

RECRUITING

Hospital Nova

Jyväskylä, Finland

RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Outcomes

Primary Outcomes

the Disabilities of Arm, Shoulder and Hand (DASH)

Minimum value 0, maximum value 100. Higher scores mean worse outcome.

Time frame: 1 year

Secondary Outcomes

the Disabilities of Arm, Shoulder and Hand (DASH)

Minimum value 0, maximum value 100. Higher scores mean worse outcome.

Time frame: 3 months

Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions

Minimum value 0, maximum value 100. Higher score indicates more pain and functional disability.

Time frame: 3 and 12 months

Pain, visual analogue scale (VAS)

Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. more pain.

Time frame: 3 and 12 months

Satisfaction, visual analogue scale (VAS)

Minimum value 0, maximum value 100. Higher scores mean worse outcome ie. less satisfactory situation.

Time frame: 3 and 12 months

Elbow X-rays

AP and lateral view.

Time frame: post-operatively, 2 weeks, 3 and 12 months

Range of elbow motion.

The results are reported in degrees. Measurement is performed to the injured arm.

Time frame: 3 and 12 months

Comparison of extension strength between injured and healthy elbow.

Both arms are measured elbow flexed 60 and 90 degrees. Power is reported in grams. Measurements are performed in sitting position, back straight.

Central Contacts

Ida Rantalaiho, MD

CONTACT

+35823135040 ida.rantalaiho@tyks.fi

Inari Laaksonen, PhD

CONTACT

inari.laaksonen@tyks.fi

Data from ClinicalTrials.gov

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