Can we improve healing in broken shin bones by changing the settings on the surgical frame that is normally used to fix these injuries?

Assessment of bone healing time in tibial fractures; Static vs variable dynamization external fixation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16465304

Enrollment

Registered

2021-05-21

Start date

2021-05-30

Completion date

Unknown

Last updated

2022-05-02

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

Conditions

Adult patients with tibial fractures Musculoskeletal Diseases

Interventions

Patients will be randomly allocated to receive either the intervention (variable reverse dynamization external fixation) or the control (standard static external fixation). This randomisation will be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients 16 years or older 2. Isolated unilateral or bilateral 41A & B, 42A B&C and 43 A tibial fractures 3. Traverse fractures, short oblique, and fractures with single butterfly 4. Where the treating surgeon believes the patients will benefit from surgical stabilisation

Exclusion criteria

Exclusion criteria: 1. More the 28 days since fracture 2. Polytrauma - closed head injury, spinal fractures, pelvis/acetabular fractures, floating knee, femoral fractures, foot/ankle fractures or dislocations, knee dislocation or ligamentous injuries 3. Comminuted and segmental fractures 4. Previous failed fixation 5. Pathologic fracture 6. Patient is/would be unable to understand instructions for treatment 7. Patient declines consent to participate 8. Pregnant

Design outcomes

Primary

Measure	Time frame
Time to bone healing, measured using the Radiographic union (RUST) score at 3, 6, 12 weeks and every following 6 weeks until radiographically united (RUST score 9 or above)	—

Secondary

Measure	Time frame
1. Ankle function according to patient measured using Olerud and Molander Ankle score at baseline, 3, 6 and 12 months after frame removal 2. Health-related quality of life measured using EuroQol 5 Dimensions score at baseline, 3, 6 and 12 months after frame removal 3. Knee function according to patient measured using Oxford knee score at baseline, 3, 6 and 12 months after frame removal 4. Complications measured using case report forms and hospital records at 3, 6 and 12 months 5. Resource use and work impact measured using questionnaires and hospital records at 3, 6 and 12 months	—

Measure

Time frame

1. Ankle function according to patient measured using Olerud and Molander Ankle score at baseline, 3, 6 and 12 months after frame removal 2. Health-related quality of life measured using EuroQol 5 Dimensions score at baseline, 3, 6 and 12 months after frame removal 3. Knee function according to patient measured using Oxford knee score at baseline, 3, 6 and 12 months after frame removal 4. Complications measured using case report forms and hospital records at 3, 6 and 12 months 5. Resource use and work impact measured using questionnaires and hospital records at 3, 6 and 12 months

—

Countries

England, United Kingdom

Outcome results

None listed

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