Clinical trial NCT01939808: Flexor Tendon Injury Rehabilitation Regime Study
Official title: Comparison of the Effect of Splinting the Wrist in Extension Versus Neutral Positioning During Rehabilitation Following Zone I/II Flexor Tendon Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Flexor Tendon
Lead sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Primary inclusion criteria for the study is patients who have had 100% division by sharp laceration to the Flexor Digitorum Profundus (FDP+)/Flexor Digitorum Superficialis (FDS) within zone I or II and who have undergone repair with cruciate and epitendinous suture. Patients with multiple digit involvement will be included in the study.
* All repairs performed with 3/0 prolene suture cruciate repair and 6/0 prolene for the epitendinous repair as per departmental protocol.
* Patients with digital nerve repair along with the above injury will be included in the study

Exclusion Criteria:

* Patients with associated phalangeal fractures, skin and soft tissue loss or who had vascular compromise will be excluded from the study.
* Patients with tendon repairs other than cruciate will be excluded from the study

Primary outcomes:
measure: Assessing the Range of Movement up to 26 week post surgery
timeFrame: up to 26 weeks post surgery
Secondary outcomes:
measure: Assessment of Grip Strength at 12 and 26 weeks post surgery
timeFrame: 12 & 26 weeks post surgery
Other outcomes:
measure: assessing for flexor tendon rupture
timeFrame: 26 weeks post surgery
Locations:
city: Prescot
country: United Kingdom
facility: Whiston Hospital
Study officials:
References: