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Treatment of Olecranon Fractures in the Elderly

ConditionOlecranon Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorOslo University Hospital

About this trial

Operative treatment, with tension band wiring or plate fixation, will be compared with non-operative treatment of displaced olecranon fractures (Mayo classification 2A and 2B) in patients 75 years or older.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Displaced olecranon fracture (Mayo 2A and 2B).

Disqualifiers

Associated fractures in the coronoid process, radial head or distal humerus.

Open fracture, Gustilo-Andersen 2 or 3

Severe cardiopulmonary disease or other medical condition which contraindicates surgery.

Previous injury to or other condition in the elbow with serious functional impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tension band wiring or plate fixation

    Procedure/Surgery

    Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.

  • Active non-operative treatment with optional plaster cast

    Procedure/Surgery

    Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: OperativeActive comparator 1 intervention
Group B: Non-operativeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Oxford Elbow Score

Patient reported 12 item form, 0 (worst) to 100 (best possible score)

Time frame
52 weeks

Secondary outcomes

1

Range of motion

Extension, flexion, rotation

Time frame
6 weeks
2

Range of motion

Extension, flexion, rotation

Time frame
12 weeks
3

Range of motion

Extension, flexion, rotation measured in degrees total movement for each direction.

Time frame
52 weeks
4

Elbow extension strength

Strength measured isometrically on a scale (grams) with elbow in 30 degrees flexion. Both arms measured for comparison.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oslo University Hospital

Lead sponsor

Source ClinicalTrials.gov
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