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Flexor Tendon Injury Rehabilitation Regime Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01939808
Recruitment Status : Withdrawn (study never started)
First Posted : September 11, 2013
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
St Helens & Knowsley Teaching Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Flexor Tendon Other: Splint Neutral Other: Splint Extended Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Splinting the Wrist in Extension Versus Neutral Positioning During Rehabilitation Following Zone I/II Flexor Tendon Repair
Actual Study Start Date : August 15, 2013
Actual Primary Completion Date : June 24, 2016
Actual Study Completion Date : June 24, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Wrist splinted in extended position
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
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



Primary Outcome Measures :
  1. Assessing the Range of Movement up to 26 week post surgery [ Time Frame: up to 26 weeks 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.


Secondary Outcome Measures :
  1. Assessment of Grip Strength at 12 and 26 weeks post surgery [ Time Frame: 12 & 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


Other Outcome Measures:
  1. assessing for flexor tendon rupture [ Time Frame: 26 weeks post surgery ]
    flexor tendon rupture to be identified by 26 weeks post surgery.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939808


Locations
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United Kingdom
Whiston Hospital
Prescot, United Kingdom, L35 5DR
Sponsors and Collaborators
St Helens & Knowsley Teaching Hospitals NHS Trust

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Responsible Party: St Helens & Knowsley Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01939808     History of Changes
Other Study ID Numbers: RBN854-STHK
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: November 2015