Flexor Tendon Injury Rehabilitation Regime Study

Flexor Tendon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01939808
• Other study ID #: RBN854-STHK
• Status: Withdrawn
• Phase: N/A
• Start date: August 15, 2013
• Est. completion date: June 24, 2016

Study information

• Verified date: November 2015
• Source: St Helens & Knowsley Teaching Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 24, 2016
• Est. primary completion date: June 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Flexor Tendon

Intervention

Other:
• Splint Neutral

• Splint Extended

Locations

Country	Name	City	State
United Kingdom	Whiston Hospital	Prescot

Sponsors (1)

Lead Sponsor	Collaborator
St Helens & Knowsley Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	assessing for flexor tendon rupture	flexor tendon rupture to be identified by 26 weeks post surgery.	26 weeks post surgery
Primary	Assessing the Range of Movement up to 26 week post surgery	The primary outcome measures will be "Range of Movement" (ROM). Total active motion will be measured using a Roylan finger goniometer following a standardised procedure and recorded on an electronic audit form (Appendix 1.5). This will be recorded up to 26 weeks post surgeries. Outcome data will be taken and recorded by a senior hand therapist who will be blinded to the position of splintage that has been worn by the participant.	up to 26 weeks post surgery
Secondary	Assessment of Grip Strength at 12 and 26 weeks post surgery	grip strength will be measured at both 12 and 26 weeks post surgery assessing change. This will be measured my using a Jamar Dynamometer and taken following a standard Procedure	12 & 26 weeks post surgery