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A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033174
Enrollment
Unknown
Registered
2020-05-23
Start date
2015-05-20
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Extra articular Pilon Fracture

Interventions

Sponsors

Ghurki Trust and Teaching hospital, Lahore, Pakistan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Patients will be eligible for this study if: Aged 16 years or over; Patients with a fracture that involves the distal tibial metaphysisdefined as a fracture extending within 2 Müller squares of the ankle joint21are eligible if: The fracture is closed; In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture.

Exclusion criteria

Exclusion criteria: Patients will be excluded from participation in this study if: In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing; The fracture is open; There is a contra-indication to anaesthesia; There is evidence that the patient would be unable to adhere to trial procedures or complete questionnaires The fracture extends into the ankle joint (ie, intra-articular fracture). Contraindications to intramedullary nailing are: the medullary canal is too narrow OR there is a preinjury deformity of the medullary canal OR it is not possible to achieve fixation of four cortices with screws distal to the fracture. We feel that these exclusion criteria will be easily understood by the surgeons and are in keeping with the pragmatic nature of the trial. However, we will include the specific reason in the trial screening data. For those patients withdrawing from the trial after written consent has been obtained, data obtained up until the point of withdrawal will be included in the final analysis.

Design outcomes

Primary

MeasureTime frame
Patient Reported Outcomes;

Countries

Pakistan

Contacts

Public ContactEjaz Ali Chaudhry

Ghurki Trust and Teaching Hospital

dr.aliejaz84@gmail.com+44 73 09026936

Outcome results

None listed

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