Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01939808

Flexor Tendon Injury Rehabilitation Regime Study

Comparison of the Effect of Splinting the Wrist in Extension Versus Neutral Positioning During Rehabilitation Following Zone I/II Flexor Tendon Repair

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
St Helens & Knowsley Teaching Hospitals NHS Trust · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

Hand flexor tendons bend the fingers down towards the palm, and can be cut during a sharp penetrating injury (e.g. from a knife or saw). Damaged flexor tendons are repaired surgically with sutures (stitches). After repair, a splint is applied to the fingers, hand and wrist for six to twelve weeks to protect the repair while the tendon heals and regains its normal strength. Most rehabilitation protocols use a splint in which the wrist position is kept straight (neutral) or bent (flexed). Some groups have described splinting with the wrist cocked back (extended) and have made the argument that this may improve outcomes, as experimental data suggests that splinting the hand with the wrist extended increases the range of movement of the repaired flexor tendon (excursion), and therefore reduces the chance of the tendon sticking down to the surrounding tissues (adhesion). Previous studies have shown no adverse effects from splinting hands with the wrist extended, and no evidence tells us which wrist splint position is better (a state of clinical equipoise or apparently equivalent outcomes). This randomised trial aims to produce this evidence, and therefore improve functional outcomes for patients in future. We propose to carry out a study to compare the outcomes (grip strength and range of movement) of flexor tendon repair in two groups of patients: one with wrists splinted in a neutral position and the other splinted in an extended position during their postoperative rehabilitation. No changes will be made to patient assessment and management,the surgery undertaken and the rehabilitation regime other than those to splint position. Previous work suggests that both positions are safe and effective. Informed consent will be obtained from all patients enrolled in the trial, and we aim to find out if the extended splint position produces better functional results.

Conditions

Interventions

TypeNameDescription
OTHERSplint Neutral
OTHERSplint Extended

Timeline

Start date
2013-08-15
Primary completion
2016-06-24
Completion
2016-06-24
First posted
2013-09-11
Last updated
2019-04-19

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01939808. Inclusion in this directory is not an endorsement.