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IRCT20221231056999N1 IRCT 2023-02-20 Mayo Hospital, Lahore Comparison of treatment of Volar Barton fracture with T plate using distal end screws and without distal end screws Comparison of treatment of Volar Barton fracture with T plate using distal end screws and without distal end screws 2023-03-01 anticipated 60 Complete https://irct.ir/trial/68478 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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). N/A Volar barton Fracture. Intervention 1: 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 FCR tendon was exposed which was retracted ulnar ward then the far side of the tendon sheath was incised to expose flexor policis longus tendon.the tendon was also retracted ulnar ward.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. Intervention 2: 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 FCR tendon was exposed which was retracted ulnar ward then the far side of the tendon sheath was incised to expose flexor policis longus tendon.the tendon was also retracted ulnar ward.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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We are yet to decide about data sharing of this research.
public Muhammad Aamir
Street No.1
Bahawalpur Pakistan 63100 +92 321 6801143 aamir@resntec.com RESnTEC scientific Muhammad Aamir
Street No.1
Bahawalpur Pakistan 63100 +92 321 6801143 aamir@resntec.com RESnTEC Pakistan Patients having closed volar Barton’s fracture with Mehara classification types-1 & II. Presenting within 5 days of fracture. 18 years 60 years Both 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. Treatment - Surgery Treatment - Surgery 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. 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. 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. Pain, healing and callous formation. Timepoint: 0-days, 14th day, 28th day, 90th day. Method of measurement: Clinical and physical examination. Mayo Hospital, Lahore Approved 2020-11-14 Institutional Review Board, King Edward Medical University New Anarkali Lahore Punjab Pakistan