Segmental tibial fracture fixation - a feasibility study

Segmental Tibial Fractures, reamed Intramedullary nailing versus circular Frame external Fixation - a feasibility study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11229660

Enrollment

Registered

2019-05-10

Start date

2019-05-13

Completion date

Unknown

Last updated

2021-04-26

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

Conditions

Segmental tibial fractures Injury, Occupational Diseases, Poisoning

Interventions

Participants will be assigned to receive an intramedullary nail or a circular frame external fixation. A web-based randomisation system will be used and the allocations will be computer generated with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults (16 years and over) with a segmental tibial fracture (open or closed) deemed suitable for either an intramedullary nail or an external fixation

Exclusion criteria

Exclusion criteria: 1. Patients under 16 2. Prior failed fixation 3. Pathological fracture 4. Infection present 5. Pre-existing (pre-injury) skin condition which precludes open surgery 6. Patient is/would be unable to understand instructions for treatment* 7. Patient is unable to complete the follow-up requirements 8. More than 21 days since injury

Design outcomes

Primary

Measure	Time frame
The feasibility of a multicentre randomised controlled trial comparing intramedullary nailing (IN) with circular frame external fixation (CFEF), measured through the rates of recruitment and retention in a randomised pilot study over the 21-month study period.	—

Secondary

Measure	Time frame
1. Conflicts or areas of concern for the research pathway compared with the existing clinical pathway, measured through the identification of all adults with segmental tibial fractures, recording the rationale for eligibility and the reasons why eligible patients do not enter the study. Interviews with patients and staff will explore this further. This will be measured over the 21 month study period 2. Compliance with the randomised allocation, measured by the completion of allocated surgical procedure over the 6-month recruitment period. 3. Standard deviation of the outcome measure Disability Rating Index to estimate the definitive sample size. This will be measured using the Disability Rating Index 6 months after randomisation 4. Feasibility of a definitive economic evaluation of IN versus CFEF, measured using Health Resource Use information 6 months after randomisation 5. Quality of life post-fixation, measured using Pittsburgh Sleep Quality Index, Tampa Scale of Kinesiophobia and EQ-5D-5L 6 months after randomisation 6. Healing rates, measured by radiological images assessed by the RUST score 6 months after randomisation 7. Current post-operative rehabilitation regimes, measured through a rehabilitation survey sent to healthcare professionals, and through interviews with staff and patients to identify current experience of rehabilitation. This will be measured over the 21 month study period 8. The variability of patient experiences of injury, treatment and recovery, such as pain, mobility, emotions and body image, across the two treatment options. This will be measured using interviews with patients to gain a detailed understanding of the impact of both treatments and outcomes important to them. This will be measured over the 21 month study period 9. The views of clinicians and patients on the factors that facilitate or inhibit trial re	—

Measure

Time frame

1. Conflicts or areas of concern for the research pathway compared with the existing clinical pathway, measured through the identification of all adults with segmental tibial fractures, recording the rationale for eligibility and the reasons why eligible patients do not enter the study. Interviews with patients and staff will explore this further. This will be measured over the 21 month study period 2. Compliance with the randomised allocation, measured by the completion of allocated surgical procedure over the 6-month recruitment period. 3. Standard deviation of the outcome measure Disability Rating Index to estimate the definitive sample size. This will be measured using the Disability Rating Index 6 months after randomisation 4. Feasibility of a definitive economic evaluation of IN versus CFEF, measured using Health Resource Use information 6 months after randomisation 5. Quality of life post-fixation, measured using Pittsburgh Sleep Quality Index, Tampa Scale of Kinesiophobia and EQ-5D-5L 6 months after randomisation 6. Healing rates, measured by radiological images assessed by the RUST score 6 months after randomisation 7. Current post-operative rehabilitation regimes, measured through a rehabilitation survey sent to healthcare professionals, and through interviews with staff and patients to identify current experience of rehabilitation. This will be measured over the 21 month study period 8. The variability of patient experiences of injury, treatment and recovery, such as pain, mobility, emotions and body image, across the two treatment options. This will be measured using interviews with patients to gain a detailed understanding of the impact of both treatments and outcomes important to them. This will be measured over the 21 month study period 9. The views of clinicians and patients on the factors that facilitate or inhibit trial re

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026