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van CCT (UK)

van CCT (UK)

Hand function 7 – 10 years after surgical repair of flexor tendon ruptures.

- candidate number14273
- NTR NumberNTR3832
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-jan-2013
- Secondary IDs2012/348 METC UMCG
- Public TitleHand function 7 – 10 years after surgical repair of flexor tendon ruptures.
- Scientific TitleHand function 7 – 10 years after surgical repair of flexor tendon ruptures.
- hypothesisTo determine the outcome of hand function of (ex)patients with flexor tendon rupture 7 – 10 years after surgical repair. We expect that subjects with flexor tendon injury have significantly worse hand function than healthy subjects.
- Healt Condition(s) or Problem(s) studiedFlexor tendon injury, Flexor tendon rupture
- Inclusion criteria1. Patients who had flexor tendon injury from August 1, 2003 until December 31, 2005;
2. Complete sharp transsection of at least a flexor digitorum superficialis (FDS) or flexor digitorum profundus (FDP) tendon;
3. Age 18 – 65;
4. Patient was eligible for tenorraphy and postoperative dynamic splint therapy.
- Exclusion criteria1. Subjects with fractures, tendon ruptures and impaired motor function due to a nerve lesion or (pre-existent) upper extremity disorders that can influence the outcome measures;
2. Legally incapacitated patients.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-feb-2013
- planned closingdate1-jun-2013
- Target number of participants28
- InterventionsHand function test consisting of:
1. Range of motion;
2. Grip- and pinchstrength;
3. Michigan Hand Questionnaire;
4. 9-hole Peg test;
5. Visual Analogue Scale;
6. Response Time.
- Primary outcomePassive and active joint mobility.
- Secondary outcome1. Strength;
2. Patient Satisfaction;
3. Fine manual dexterity;
4. Self-measured handiness;
5. Response Time Test.
- TimepointsOne moment of testing (follow-up of a study performed 7 years ago).
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryFlexor tendon injury is one of the most common hand injuries and usually happens as an accident with a sharp object. Surgical repair is necessary to allow the patient to flex their fingers again. A dynamic splint is placed after the procedure to prevent adhesions and re-rupture at the same time. The longterm outcome of flexor tendon injury is still unclear. This study could be considered as a follow-up of Dr. M.W. Stenekes “Cerebral Reorganization and Motor Imagery after Flexor Tendon Repair, 2009” The same patients (n=28) will be used for a last measurement of hand function consisting of: range of motion, grip- and pinchstrength, MHQ, 9-hole Peg Test, VAS and response time test. The results will allow us to determine the overall hand function of flexor tendon patients. The patients hand function with will also be compared with normative data based on literature. The testing will take place in the University Medical Center Groningen in The Netherlands. Knowing more about the long term outcome could provide doctors with better patient education.
- Main changes (audit trail)
- RECORD28-jan-2013 - 13-feb-2013

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