Comparison between treatment outcomes of soft tissue distraction in addition to Z-plasty and Z-plasty alone after skin graft in patients with chronic flexion contracture of interphalangeal joints due to previous traumatic abrasive injuries
Aim: Interphalangeal (IP) joint contracture is a common and challenging complication of hand trauma. Several techniques for soft tissue distraction has been developed during the past few decades. Pentagonal frame is the latest technique that was introduced in 2009 as effective method for treatment of flexion contractures of hand. Study population: In this study, patients with chronic flexion contracture of interphalangeal joints following trauma will be treated using two surgical techniques in two groups each containing 20 patients. Major inclusion and exclusion criteria: Patients with long-standing scars on fingers for more than 6 months after the trauma with a history of unsuccessful medical treatment for the past 6 months will be evaluated. Patients with history of muscular or bone injuries of the fingers, acute inflammation, sensory, motor or vascular problem within the hand will be excluded. Intervention: In the first group soft tissue distraction using pentagonal frame following scar release using Z-plasty in the treatment of post-traumatic long-standing flexion contracture of proximal and distal interphalangeal joints and in the second group multiple Z-plasties alone will be done alone. Primary outcomes: after surgical intervention, flexion contracture and range of motion in interphalangeal joints will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201298861N1
Registration date:2012-03-15, 1390/12/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-03-15, 1390/12/25
Registrant information
Name
Mohammad Reza Keramati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1657
Email address
mr-keramati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2011-08-01, 1390/05/10
Expected recruitment end date
2012-02-01, 1390/11/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between treatment outcomes of soft tissue distraction in addition to Z-plasty and Z-plasty alone after skin graft in patients with chronic flexion contracture of interphalangeal joints due to previous traumatic abrasive injuries
Public title
Soft tissue distraction using pentagonal frame in long standing traumatic flexion deformity of interphalangeal joints
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with long-standing scars on fingers for more than 6 months after the trauma with a history of unsuccessful medical treatment for the past 6 months. Exclusion criteria: history of muscular and/or bone injuries of the fingers (only pure cutaneous and subcutaneous traumatic injuries resulting scar formation will be studied); Bone fracture (using X-rays); acute inflammation or granulation tissue; History of other medical comorbidities including medical or surgical problems, immune-suppression; previous history of surgery in the involved hand; any previous traumatic injuries of the hand; physical exam revealing any sensory, motor or vascular problem within the hand.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
6th floor, Central building of Tehran university of medical sciences, Ghods St., Keshavarz Ave.
City
Tehran
Postal code
Approval date
2011-08-01, 1390/05/10
Ethics committee reference number
695/130/د/90
Health conditions studied
1
Description of health condition studied
Flexion contracture of proximal and distal interphalangeal finger joints
ICD-10 code
M20.0
ICD-10 code description
Deformity of finger(s)
Primary outcomes
1
Description
Degree of flexion contracture of proximal interphalangeal finger joints
Timepoint
before surgery, six months after surgery
Method of measurement
Degree using measure
2
Description
Degree of flexion contracture of distal interphalangeal finger joints
Timepoint
before surgery, six months after surgery
Method of measurement
Degree using measure
Secondary outcomes
1
Description
Range of motion of proximal interphalangeal finger joint
Timepoint
before surgery, six months after surgery
Method of measurement
degree using measure
2
Description
Range of motion of distal interphalangeal finger joint
Timepoint
before surgery, six months after surgery
Method of measurement
degree using measure
Intervention groups
1
Description
Group A (intervention) : Soft tissue distraction will be performed using pentagonal frame technique. In this method, primarily, scars and contractures will be released using single or multiple Z or zigzag incisions for lengthening. A Kirschner wire size 1–1.5 mm (matching the patient’s distal phalanx thickness) will be used for anchorage. The wire wll be passed horizontally, under direct fluoroscopic control, through the head of the phalanx and then bent like a pentagon. Before closing the wire ends, a rubber band will be inserted inside the frame. The frame will be shaped such that only the horizontal wire segment exerts the ‘‘distraction,’’ and no vascular compromise or soft tissue encroachment will be created. An external fixation device will then be used to distract the finger.
Category
Treatment - Surgery
2
Description
Group B (Control) : In this group, scars and contracture will be release using single or multiple Z or zigzag incisions for lengthening. Then, a splint will be used to hold the finger in full extension position.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran university of medical sciences, Firoozgar hospital
Full name of responsible person
Dr. Mohammad Reza Keramati
Street address
Behafarin St, Karimkhan Ave, Valie-asr Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Researach deputy of Tehran university of medical sciences, Faculty of medicine
Full name of responsible person
Dr. Shahin Akhoondzadeh
Street address
Faculty of medicine, Poor-sina St, Shanzdah-azar St, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researach deputy of Tehran university of medical sciences, Faculty of medicine
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Resident of surgery
Other areas of specialty/work
Street address
Apt.43, No.32, Parastoo St., Kamraniye Ave.
City
Tehran
Postal code
1951955531
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Resident of surgery
Other areas of specialty/work
Street address
Apt.43, No.32, Parastoo St., Kamraniye Ave.
City
Tehran
Postal code
1951955531
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Dr. Mohammad Reza Keramati
Position
Resident of surgery
Other areas of specialty/work
Street address
Apt.43, No.32, Parastoo St., Kamraniye Ave.
City
Tehran
Postal code
1951955531
Phone
+98 21 2283 3381
Fax
Email
mr-keramati@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)