A comparison of two methods of surgical fixation for the treatment of simple olecranon fractures in adults

Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial (Simple Olecranon Fracture Fixation Trial – SOFFT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87904264

Enrollment

280

Registered

2020-05-19

Start date

2020-10-13

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Olecranon fracture Injury, Occupational Diseases, Poisoning Fracture of upper end of ulna

Interventions

This is a multi-centre, randomised controlled non-inferiority trial, with an internal pilot phase to check the assumptions about recruitment and provide guidance on optimising the trial processes. Th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged > = 16 years 2. Mayo Grade IIA acute olecranon fracture within 3 weeks of injury 3. Closed or Gustillo and Anderson grade 1 open injury 4. The surgeon believes the patient will benefit from surgical intervention 5. Ability to give informed consent

Exclusion criteria

Exclusion criteria: 1. Surgery contra-indicated 2. Gustillo and Anderson grade 2 or 3 open injury 3. Associated upper limb injuries or prior upper limb pathology adversely affecting function 4. Evidence of fracture comminution (Mayo Grade IIB) or instability around the elbow and/or forearm (Mayo Grade III) 5. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires 6. Previous entry into SOFFT 7. Concurrent olecranon fracture in the opposite limb

Design outcomes

Primary

Measure	Time frame
Physical function of the upper limb measured using the Disabilities of the Arm Shoulder and Hand (DASH) score at 4 months	—

Secondary

Measure	Time frame
Collected at 4, 12 and 18 months post-randomisation for the whole population, and at 24 months post-randomisation only for those who reach that follow-up point within the trial recruitment and follow-up window of up to month 48 of the study (unless stated otherwise): 1. Physical function of the upper limb measured using the Disabilities of the Arm Shoulder and Hand (DASH) score at 12, 18, and 24 months 2. Pain measured using a Numeric Rating Scale 3. Patient satisfaction measured using a Net Promotor Score 4. Health-related quality of life measured using EuroQol 5 Dimensions (5L) Score (EQ5D-5L). EQ-5D-5L data will be collected twice at baseline: i.e. once to assess patient health-related quality of life on the day (after the injury) and once with regard to the week before injury. 5. Radiological union measured using x-ray imaging at 4 months 6. Complications collected by patient-reported questionnaires and review of hospital records 7. Elbow range of movement (flexion, extension, pronation and supination) assessed by a suitably trained independent observer using a hand-held goniometer following trial-specific instructions at 4 months 8. Re-operations related to the injury or to remove metalwork; reason for reoperation will be recorded 9. Resource use and work impact: patient-reported questionnaires and hospital forms will be designed to collect information on hospital stay (initial and subsequent inpatient episodes, outpatient hospital visits and A&E admissions); primary care consultations (e.g. GP, nurse and physiotherapy); work impact of both interventions; and return to work and return to normal activities.	—

Measure

Time frame

Collected at 4, 12 and 18 months post-randomisation for the whole population, and at 24 months post-randomisation only for those who reach that follow-up point within the trial recruitment and follow-up window of up to month 48 of the study (unless stated otherwise): 1. Physical function of the upper limb measured using the Disabilities of the Arm Shoulder and Hand (DASH) score at 12, 18, and 24 months 2. Pain measured using a Numeric Rating Scale 3. Patient satisfaction measured using a Net Promotor Score 4. Health-related quality of life measured using EuroQol 5 Dimensions (5L) Score (EQ5D-5L). EQ-5D-5L data will be collected twice at baseline: i.e. once to assess patient health-related quality of life on the day (after the injury) and once with regard to the week before injury. 5. Radiological union measured using x-ray imaging at 4 months 6. Complications collected by patient-reported questionnaires and review of hospital records 7. Elbow range of movement (flexion, extension, pronation and supination) assessed by a suitably trained independent observer using a hand-held goniometer following trial-specific instructions at 4 months 8. Re-operations related to the injury or to remove metalwork; reason for reoperation will be recorded 9. Resource use and work impact: patient-reported questionnaires and hospital forms will be designed to collect information on hospital stay (initial and subsequent inpatient episodes, outpatient hospital visits and A&E admissions); primary care consultations (e.g. GP, nurse and physiotherapy); work impact of both interventions; and return to work and return to normal activities.

—

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026