Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001109897
Ethics application status
Approved
Date submitted
11/10/2012
Date registered
17/10/2012
Date last updated
17/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial to compare the outcome of two different repair techniques in patients with flexor tendon injuries in their hand
Scientific title
Comparison of outcome of 1- and 2-knot, 4-strand, double-modified Kessler flexor tendon repair with early active mobilization protocol in patients with flexor tendon lacerations of hand
Secondary ID [1] 281381 0
NIL
Universal Trial Number (UTN)
U1111-1135-7623
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Flexor tendon injuries of the hand. 287610 0
Condition category
Condition code
Injuries and Accidents 287942 287942 0 0
Other injuries and accidents
Musculoskeletal 287956 287956 0 0
Other muscular and skeletal disorders
Surgery 287957 287957 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is comparison of two different surgical techniques for flexor tendon repair. 1knot technique(Group A) or 2 knot technique(Group B) with approximate duration of 60-120 min in both techniques. Early active mobilization of affected digits will be started from 1st postoperative day in both groups.Patients will follow this rehabilitation protocol for 8 weeks ,with change of exercises will be told to patients on followups.
Intervention code [1] 285854 0
Treatment: Surgery
Comparator / control treatment
Group A patients will have 1 knot for flexor tendon repair while group B patients will have 2 knots.Group A can be described as control treatment.
Control group
Active

Outcomes
Primary outcome [1] 288150 0
1-knot flexor tendon repair is stronger than 2-knot repair in term of total active motion
Timepoint [1] 288150 0
Total active motion 3, 6 and 8 weeks postoperatively and a final assessment performed at 12 weeks postoperatively.Total active motion will assessed with by goniometry.
Secondary outcome [1] 299511 0
Tendon rupture
Timepoint [1] 299511 0
At 3, 6 and 8 weeks postoperatively and a final assessment performed at 12 weeks postoperatively by clinical examination .In suspicious cases Ultrasonic exam will be done.

Eligibility
Key inclusion criteria
Age 5 to 70 years
Gender both males and females
Flexor tendon lacerations of hand (on clinical examination)
Minimum age
5 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Associated extensor tendon lacerations of hand (on clinical examination)
Associated fractures of hand (on X rays of affected hand)
Replantation and revascularization cases of hands (on clinical examination)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using lottery method
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4595 0
Pakistan
State/province [1] 4595 0

Funding & Sponsors
Funding source category [1] 286133 0
Self funded/Unfunded
Name [1] 286133 0
Country [1] 286133 0
Primary sponsor type
Individual
Name
Muhammad Saleem
Address
Department of Plastic Surgery, Allama Iqbal Medical College,
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country
Pakistan
Secondary sponsor category [1] 284944 0
None
Name [1] 284944 0
Address [1] 284944 0
Country [1] 284944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288180 0
Ethical Review Board, Allama Iqbal Medical College, Jinnah Hospital
Ethics committee address [1] 288180 0
Prof. Arif M. Siddiqui
Chairman Ethical Review Board,
Medica Unit 3
Allama Iqbal Medical College, Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Ethics committee country [1] 288180 0
Pakistan
Date submitted for ethics approval [1] 288180 0
Approval date [1] 288180 0
30/12/2011
Ethics approval number [1] 288180 0

Summary
Brief summary
The objective of the study is to compare the outcome of flexor tendon repair techniques in term of total active motion between two groups. Flexor tendon repair will be done by consultant using 4 strands of double modified Kessler grasping core suture 4-0 polypropylene suture material with 1 knot(Group A) or 2 knot (Group B) placed between tendon ends. Both groups will undergo early active mobilization protocol starting from first post operative day. All patients will be clinically assessed in term of total active motion 3, 6 and 8 weeks postoperatively and a final assessment performed at 12 weeks postoperatively by the researcher and data will be entered in the proforma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34819 0
Address 34819 0
Country 34819 0
Phone 34819 0
Fax 34819 0
Email 34819 0
Contact person for public queries
Name 18066 0
Muhammad Saleem
Address 18066 0
Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 18066 0
Pakistan
Phone 18066 0
+923445203650
Fax 18066 0
Email 18066 0
[email protected]
Contact person for scientific queries
Name 8994 0
Muhammad Saleem
Address 8994 0
Department of Plastic Surgery
Allama Iqbal Medical College/ Jinnah Hospital
Allama Shabbir Ahmed Usmani Road,
Lahore 54550
Country 8994 0
Pakistan
Phone 8994 0
+923445203650
Fax 8994 0
Email 8994 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.