To compare treatment of volar Barton’s fracture with T plate using distal end screws and without using distal end screws in terms of pain, range of motion (ROM), grip strength and activities compared to opposite side.
Design
An open labelled, randomized controlled trial with parallel group designed of 60 patients, enrolling between March 2023 to December 2023.
Settings and conduct
This open label randomized controlled trial be conducted at the Department of Orthopedics unit-2 Mayo Hospital Lahore, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients of either gender aged 18-60 years with closed volar Barton’s fracture with Mehara classification types-1 & II of duration < 5 days. Exclusion criteria were patients with infections, extensive comminution, open fracture with extensive soft tissue damage or contamination, neurological deficit, head injury or major vascular injury, ipsilateral upper limb trauma or those non-compliant to postoperative physiotherapy and follow up. Patients with severe osteoporosis or those with reduced functional requirement of wrist were also excluded.
Intervention groups
In Group-A, patients were used T-plate with distal end screws and in Group-B, patients were used T-plate without distal end screws.
Main outcome variables
Pain, range of motion (ROM), grip strength and functional outcomes as per volar Barton’s fracture using Green O Brien scoring
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221231056999N1
Registration date:2023-02-20, 1401/12/01
Registration timing:prospective
Last update:2023-02-20, 1401/12/01
Update count:0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
M Aamir
Name of organization / entity
RESnTEC, Institute of Research
Country
Pakistan
Phone
+92 321 6801143
Email address
aamir@resntec.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-01, 1401/12/10
Expected recruitment end date
2023-12-30, 1402/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of treatment of Volar Barton fracture with T plate using distal end screws and without distal end screws
Public title
Comparison of treatment of Volar Barton fracture with T plate using distal end screws and without distal end screws
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having closed volar Barton’s fracture with Mehara classification types-1 & II.
Presenting within 5 days of fracture.
Exclusion criteria:
Patients with infections, extensive comminution, open fracture with extensive soft tissue damage or contamination, neurological deficit, head injury or major vascular injury, ipsilateral upper limb trauma or those non-compliant to postoperative physiotherapy and follow up.
Patients with severe osteoporosis or those with reduced functional requirement of wrist were also excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly allocated to either T plate using distal end screws or T plate without distal end screws. The lottery method will be performed for randomization. A total of 60 paper slips will be folded and mixed in a lottery box. Then these 60 slips will be randomly divided in to either Group-1 (T plate using distal end screws) or Group-2 (T plate without distal end screws). Equal number of patients will be randomly allocated to both groups (30 in each group).
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
Institutional Review Board, King Edward Medical University
Street address
New Anarkali
City
Lahore
Postal code
54700
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
843/RC/KEMU
Health conditions studied
1
Description of health condition studied
Volar barton Fracture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Functional outcome as per Green & O'Brien Score. This is an examiner-rated assessment of pain, functional status, range of motion, and grip strength. Each of the 4 parameters is given a weighting of 25 points, giving a total score of 100. With excellent being 90 to 100, good 80 to 89, fair 65 to 79, and poor <65.
Timepoint
0-days, 14th day, 28th day, 90th day.
Method of measurement
functional outcomes as per Green & O’Brien Scoring
2
Description
Pain, healing and callous formation
Timepoint
0-days, 14th day, 28th day, 90th day.
Method of measurement
Clinical and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
The Modified Henry approach (Trans-FCR) was used to expose the fracture. Skin incision was made over flexor Carpi radialis tendon and incising the tendon sheath. FCR tendon was exposed which was retracted ulnar ward then the far side of the tendon sheath was incised to expose flexor policis longus tendon.the tendon was also retracted ulnar ward. The muscle fibres of pronator quadratus were incisedalong its radial side to expose the fracture. The 3.5mm T-Plate was used after proper reduction of fracture. T plate using distal end screws was used. Wound was closed in reverse fashion layer by layer.
Category
Treatment - Surgery
2
Description
The Modified Henry approach (Trans-FCR) was used to expose the fracture. Skin incision was made over flexor Carpi radialis tendon and incising the tendon sheath. FCR tendon was exposed which was retracted ulnar ward then the far side of the tendon sheath was incised to expose flexor policis longus tendon.the tendon was also retracted ulnar ward. The muscle fibres of pronator quadratus were incisedalong its radial side to expose the fracture. The 3.5mm T-Plate was used after proper reduction of fracture. T plate without distal end screws was used. Wound was closed in reverse fashion layer by layer.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthopedics unit II Mayo Hospital Lahore, Pakistan
Full name of responsible person
Muhammad Zarak Awais
Street address
Anarkali
City
Lahore
Postal code
54700
Phone
+92 312 6145131
Email
zarakkhan76.zk@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mayo Hospital, Lahore
Full name of responsible person
Muhammad Zarak Awais
Street address
Anarkali
City
Lahore
Postal code
54700
Phone
+92 312 6145131
Email
zarakkhan76.zk@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mayo Hospital, Lahore
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
RESnTEC
Full name of responsible person
Muhammad Aamir
Position
Research Consultant
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
RESnTEC
Full name of responsible person
Muhammad Aamir
Position
Research Consultant
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
Person responsible for updating data
Contact
Name of organization / entity
RESnTEC
Full name of responsible person
Muhammad Aamir
Position
Research Consultant
Latest degree
Bachelor
Other areas of specialty/work
Biostatistics
Street address
Street No.1
City
Bahawalpur
Province
Punjab
Postal code
63100
Phone
+92 321 6801143
Email
aamir@resntec.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available