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Recruiting NCT04670900

Treatment of Olecranon Fractures in the Elderly

No phase Interventional Olecranon Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tension band wiring or plate fixation, Active non-operative treatment with optional plaster cast.
Who it may be relevant to
Registry conditions: Olecranon Fracture. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway, Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Operative or Non-Operative Treatment of Displaced Fractures of the Elderly - a Nordic Multicenter Randomized Trial

Overview

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.

Detailed description

Displaced olecranon fractures disrupt the extensor mechanism of the elbow and operative treatment is therefore usually recommended. Tension band wiring (TBW) and plate fixation (PF) are the most common surgical treatment options. Both methods are associated with high complication and reoperation rates, especially in elderly patients. Only one randomized controlled trial has compared operative and non-operative treatment of olecranon fractures in the elderly, but the study was stopped prematurely due to high complication rates in the group treated operatively and remained underpowered for important outcome measures.A few small patient series with non-operatively treated fractures also exist and suggest that it may be a valid alternative to operative treatment

Interventions

  • Procedure Tension band wiring or plate fixation
    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.
  • Procedure Active non-operative treatment with optional plaster cast
    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.

Primary outcome measures

  • Oxford Elbow Score [Time frame: 52 weeks]
Secondary outcome measures (12)
  • Range of motion [Time frame: 6 weeks]
  • Range of motion [Time frame: 12 weeks]
  • Range of motion [Time frame: 52 weeks]
  • Elbow extension strength [Time frame: 6 weeks]
  • Elbow extension strength [Time frame: 12 weeks]
  • Elbow extension strength [Time frame: 52 weeks]
  • Elbow satisfaction [Time frame: 6 weeks]
  • Elbow satisfaction [Time frame: 12 weeks]
  • Elbow satisfaction [Time frame: 52 weeks]
  • Complications [Time frame: Through study period up to 52 weeks.]
  • Number of Reoperations [Time frame: Through study period up to 52 weeks.]
  • Oxford Elbow Score [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Norway · 11 centers
  • Baerum Hospital — Sandvika
  • Vestre Viken Hospital Trust — Hønefoss
  • St. Olavs Hospital — Trondheim
  • Arendal Hospital — Arendal
  • Haukeland University Hospital — Bergen
  • Østfold Hospital Trust — Grålum
  • Orthopedic Center, Ulleval University Hospital — Oslo
  • Diakonhjemmet Hospital — Oslo
  • … and 3 more centers
Sweden · 1 center
  • Akademiska Hospital — Uppsala

Publications

  • Savvidou OD, Koutsouradis P, Kaspiris A, Naar L, Chloros GD, Papagelopoulos PJ. Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review. EFORT Open Rev. 2020 Aug 1;5(7):391-397. doi: 10.1302/2058-5241.5.190041. eCollection 2020 Jul. PMID 32818066

Identifiers

NCT: NCT04670900 · REC2018/88

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗