Comparison of conventional hand therapy and assistive device in the rehabilitation of flexor tendon injuries

Phase 3

Completed

• Conditions: Spontaneous rupture of flexor tendons,

• Registration Number: CTRI/2019/01/016821
• Lead Sponsor: Department of Orthopaedics

Brief Summary

This study is a randomised , open labelled, parallel group, active controlled, single centre trail comparing the comparing the functional outcomes in patients with post tendon repair mobilized by conventional hand therapy and assistive device for 1.6 years in 120 patients in one centre in India.

 The primary outcome measurements will be functional outcomes: TAF and TAM (Strickland criteria and Tang criteria) Post op at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention.

 The secondary outcomes will be grip strength and pinch strength at 6 months and 12 months post intervention and Quick dash score Post op at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Last Update Posted: 2020-02-11
• Study Completion: 2020-07-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients with zone II to zone V flexor tendon injuries who have been operated by early primary tendon repair.

Exclusion Criteria

• Patients with associated fractures, nerve and vascular injury along with tendon injuries of the hand which may affect the rehabilitation.
• Patients with tendon injuries of hand with different zones in the same hand -Patients with combined flexor and extensor tendon injuries of hand.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total active flexion and Total active motion (Strictland criteria and Tang criteria)	Post operatively at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Grip strength and pinch strength	At 6 months and 12 months post intervention
Quick dash score	Postop at the time of discharge, 3 weeks, 6 weeks, 3 months, 6 months, 12 months post intervention

Trial Locations

Locations (1)

Kasturba Hopsital; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Hopsital

🇮🇳Udupi, KARNATAKA, India

Venkata Vinay Atluri

Principal investigator

7259535379

vinay10200@gmail.com