Accuracy assessment of deformity correction using computer guided newer generation external fixator in deformities of thigh and leg bones

Not yet recruiting

• Conditions: Other specified acquired deformities of musculoskeletal system,

• Registration Number: CTRI/2020/05/025480
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

This study has been designed as a prospective interventional study to evaluate the accuracy of bony alignment using computer assisted hexapod fixator in correction of long bone deformities of lower limb in patients of age group of 18-60 years. Study will be conducted in India for a duration of 1 year. Outcome of the study will be assessed by residual angulation at CORA, reference lines and angles, residual LLD, time period of deformity correction, number of correction manoeuvres required.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1.Clinico-radiologically diagnosed cases of lower limb deformities requiring treatment by Ilizarov method 2.Ilizarov fixator treated lower limb deformity cases with residual deformity after intra-operative acute correction manoeuvre.

Exclusion Criteria

1.Ilizarov fixator treated lower limb deformity cases where acceptable bony alignment could be achieved intra-operatively 2.Injuries on ipsilateral limb requiring vascular repair.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of deformity correction will be assessed by following :	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre
A.Residual Angulation at CORA	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre
Opposite side alignment values will be considered as normal reference values. In case opposite side is also involved, standard reference values will be considered as normal values for evaluation purpose.	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre
B.Reference line and angles	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre
C.Value of residual torsional component of deformity, determined clinically	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre
D.Residual Limb length discrepancy (LLD)	Primary outcomes will be assessed at two timepoints – | 1.Immediately after application of computer assisted hexapod external fixator in postoperative period | 2.After completion of software prescribed correction manoeuvre

Secondary Outcome Measures

Name	Time	Method
A.Manner’s grading of deformity (for accuracy assessment)2	B.Time period of Deformity correction

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Lok Nayak Hospital

🇮🇳Central, DELHI, India

Anubhav Vichitra

Principal investigator

9654737879

anu.thundercharge@gmail.com