Flexor Tendon Injury Rehabilitation Regime Study

NCT01939808 | Withdrawn

• 1 other identifier: RBN854-STHK
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexor Tendon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Grip Strength at 12 and 26 weeks post surgery

  12 & 26 weeks post surgery

Other Outcomes (1)

• assessing for flexor tendon rupture

  26 weeks post surgery

Study Arms (2)

Wrist splinted in extended position

OTHER

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

Other: Splint Extended

Wrist Splinted in the Neutral postion

OTHER

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

Other: Splint Neutral

Interventions

Splint Neutral OTHER

Wrist Splinted in the Neutral postion

Splint Extended OTHER

Wrist splinted in extended position

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Helens & Knowsley Teaching Hospitals NHS Trust: lead

Study Sites (1)

Whiston Hospital

Prescot, L35 5DR, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2013
• First Posted: September 11, 2013
• Study Start: August 15, 2013
• Primary Completion: June 24, 2016
• Study Completion: June 24, 2016
• Last Updated: April 19, 2019

Record last verified: 2015-11

Locations

GB (1)