CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Splinting (plaster of paris)procedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04796168
NCT04796168N/ACompleted

Post Operative Ankle Splint Study - Prospective Multi Center Randomized Controlled Trial

Kuwait Institute for Medical Specialization·interventional·Posted Mar 12, 2021·Updated Mar 8, 2023

In Brief

A clinical study evaluating Splinting (plaster of paris) for Ankle Fractures and Splints. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Background: Ankle fractures are some of the most common orthopedic presentations, however, controversy in their management and their post-operative rehabilitation protocols exist. Most displaced ankle fractures treated with anatomical reduction and stable internal fixation to allow early range of motion by allowing rigid fixation and restoration of ankle joint congruence. Post-operative rehabilitation protocols varies between surgeons and institutions with the majority emphasising early rehabilitation protocols. The use of a splint. The rational for splinting ankle fractures after rigid fixation is to decrease pain level, rest the soft tissues and prevent equinus deformity. Up to date there is no scientific research to question the benefit of routine use of splints after rigid fixation of ankle fractures. Methods: A prospective multi-centre randomised control trial. Approximately fifty patients will be enrolled from 3 hospitals (Adan, Mubarak and Farwaniya hospital) over a 1 year period. The studied sample will be randomised into 2 groups using computerised randomisation software: splint group and no-splint group. The patients will be examined at set intervals for pain, swelling, deep-vein thrombosis and a set of scoring tools. The tools include: visual analogue score (VAS) for pain, Short Form Health Survey (SF-36), American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot score, physical and radiological assessment at 2 weeks, 3 months, 6 months and 1 year intervals. Statistical Package for the Social Sciences program (SPSS) will be used for statistical analysis Results/outcomes: Functional scores, symptoms and signs, complications, radio-graphic and clinical follow up will be recorded.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKuwait
CollaboratorsKuwait University

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 12, 2021
Enrollment StartFeb 1, 2021
Primary CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.3 years ago

Interventions

Splinting (plaster of paris)procedure

Placing stockinette followed by cotton rolls and 10-12 layer of posterior ankle splint made of plaster of paris