Actively Recruiting

Phase Not Applicable
Age: 75Years +
All Genders
ID04670900

Operative or Non-Operative Treatment of Displaced Olecranon Fractures in Elderly Patients - A Nordic Multicenter Randomized Trial

Led by Oslo University Hospital · Updated on 2025-03-25

76

Participants Needed

12

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating treatments for displaced olecranon fractures in patients aged 75 years or older. These fractures affect the elbow's extensor mechanism, and surgical options like tension band wiring and plate fixation are common but come with high complication and reoperation rates, especially in elderly patients. The study aims to compare operative treatment with non-operative care to determine the best approach for this population. Patients in the study will be randomly assigned to receive either surgery or non-operative treatment. Those in the surgical group will undergo tension band wiring or plate fixation using an anatomical precontoured plate, performed by experienced surgeons according to Orthopedic Trauma Association principles. Patients in the non-operative group will be offered a plaster cast or back-slab for 1 to 2 weeks to relieve pain, which is then removed after 7 to 14 days. During the trial, participants will be monitored through various assessments over 52 weeks, including measuring elbow function with the Oxford Elbow Score, range of motion, elbow extension strength, and satisfaction. Researchers will also track complications and any reoperations throughout the study period. The total follow-up time for each participant is one year, allowing thorough evaluation of treatment outcomes and safety.

CONDITIONS

Brief Title

Treatment of Olecranon Fractures in the Elderly

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Displaced olecranon fracture classified as Mayo 2A or 2B
  • Age 75 years or older
Not Eligible

You will not qualify if you...

  • Fractures involving the coronoid process, radial head, or distal humerus
  • Open fractures classified as Gustilo-Andersen type 2 or 3
  • Severe heart or lung disease or other medical conditions that make surgery unsafe
  • Previous injury or serious functional impairment in the affected elbow

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 2 weeks

Participants randomized to operative treatment receive surgery with either tension band wiring or plate fixation performed by an experienced surgeon.

1 surgery visit and follow-up visits as needed

Treatment

Duration - 1 to 2 weeks

Participants randomized to non-operative treatment receive active non-operative care, including an optional plaster cast worn for 1 to 2 weeks.

1 to 2 visits depending on plaster cast application and removal

Post-operative Follow-up

Duration - Up to 52 weeks

Participants in both treatment groups attend follow-up visits to assess range of motion, elbow strength, satisfaction, complications, and recovery progress.

Visits at approximately 6 weeks, 12 weeks, and 52 weeks

Trial Site Locations

Total: 12 locations

1

Baerum Hospital

Sandvika, Gjettum, Norway

Actively Recruiting

2

Vestre Viken Hospital Trust

Hønefoss, Norway, Norway, 3511

Actively Recruiting

3

St. Olavs Hospital

Trondheim, Trønderlag, Norway

Actively Recruiting

4

Arendal Hospital

Arendal, Norway

Actively Recruiting

5

Haukeland University Hospital

Bergen, Norway

Actively Recruiting

6

Østfold Hospital Trust

Grålum, Norway

Actively Recruiting

7

Orthopedic Center, Ulleval University Hospital

Oslo, Norway, 0408

Actively Recruiting

8

Diakonhjemmet Hospital

Oslo, Norway

Not Yet Recruiting

9

Telemark Hospital

Skien, Norway

Actively Recruiting

10

Stavanger University Hospital

Stavanger, Norway

Actively Recruiting

11

Tønsberg Hospital

Tønsberg, Norway

Actively Recruiting

12

Akademiska Hospital

Uppsala, Sweden

Not Yet Recruiting

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Research Team

F

Frede Frihagen, PhD

K

Kaare S Midtgaard, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Displaced olecranon fractures in the elderly: outcomes after non-operative treatment - a narrative review.

Olga D Savvidou, Panagiotis Koutsouradis, Angelos Kaspiris...

https://pubmed.ncbi.nlm.nih.gov/32818066