Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201412000947268 Date of Approval: 26/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title K-Wires versus Titanium Miniplates in Unstable Phalangeal fractures
Official scientific title Kirschner Wires versus Titanium Miniplates and Screws in Management of Unstable Phalangeal Fractures Followed by Controlled Active Motion Protocol: A randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Phalangeal fractures are common hand injuries in daily work and life. They can be treated conservatively, with good results, or operatively depending on the nature of injuries, fracture pattern and the fracture stability. losed reduction with internal fixation by Kirschner wires has been widely applied in treating the unstable closed simple hand fractures. However, due to the less rigid fixation with little stability of the K-wire, it is limited in the treatment of unstable fractures, while mini-plate is considered as an alternative reliable option for unstable fractures of the hand with good stability allowing early joint mobilization and avoiding complications of protruding K-wire. Because both methods of treatment have their advantages and disadvantages, there is uncertainty regarding what is the best way to treat hand fractures. Thus, we, hereby, aim in this clinical trial to compare prospectively between the K-wires and titanium miniplates in management of unstable phalangeal fractures regarding clinical, radiological and functional patients¿ outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Phalangeal fractures,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 27/11/2014
Actual trial start date 27/11/2014
Anticipated date of last follow up 31/12/2016
Actual Last follow-up date 30/04/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Each participant will be randomly assigned following simple randomization procedure by using closed white envelops: 40 envelops assign the group to be followed. Those envelops include 20 paper charts (Fig. A) and 20 paper charts (Fig. B), which are folded three times not to show its contents to assure random assignment. WITH percutaneous K-wires fixation Figure A: Paper inside the closed white envelopes WITH open reduction and internal fixation with miniplates and screws Figure B: Paper inside the closed white envelopes. Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Open reduction and internal fixation of phalangeal fractures with miniplates and screws once dorsal, dorsolateral or midaxial approaches will be adopted. Direct reduction will be performed by using the two pointed reduction forceps. A K-wire is then inserted for preliminary fixation. A 4-5 holes 1.5-2 mm titanium miniplates and screws are then inserted. Additional lag screws can be used when independent intra-articular, long oblique or metaphyseal comminuted fragments needed to be fixed. 20
Control Group Percutaneous K-wires fixation of phalangeal fractures once Closed reduction will be achieved by applying longitudinal traction to the finger. Rotational malalignment or angular deviation should be reduced using image intensification. A K-wire is then drilled through a small stab incision in the coronal plane into the near fragment, then after confirmation of reduction, it will be advanced into the far fragment. The wire tip engages the opposite cortex. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Male and female patients - All ages - Patients with unstable phalangeal fractures, closed or clean open fractures - No previous surgeries in the finger - No medical contraindications to surgery - Patients are keen to provide informed consent. - Patients with pathological fractures - Finger joint stiffness - Arthritic changes - Open or intra-articular fracture - Associated tendon injury 6 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/11/2014 High Research Ethics Committee, Faculty of Medicine, Suez Canal University
Ethics Committee Address
Street address City Postal code Country
4.5 Km Ring road Ismailia 41111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Radiological outcome: fracture healing and osteoarthritic changes to the finger joint. Bone union, which is defined as the disappearance of fracture lines. - 1 weeks postoperative - 4 weeks postoperative - 8 weeks postoperative - 12 weeks postoperative - 6 months postoperative
Primary Outcome Clinical outcome: Postoperative pain will be assessed using the visual analogue scale. Range of motion of the affected digit will be measured using a standard goniometer and will be evaluated as a proportion of total active motion (%TAM) relative to the contralateral side. Other objective assessments include measurement of grip and pinch strengths and the presence of postsurgical complications. - 1 weeks postoperative - 4 weeks postoperative - 8 weeks postoperative - 12 weeks postoperative - 6 months postoperative - 12 months postoperative
Primary Outcome Functional outcomes: The Arabic version of the disabilities of the arm, shoulder and hand questionnaire (DASH score) and Steel's method will be used to assess the patients¿ functional outcome. - 1 weeks postoperative - 4 weeks postoperative - 8 weeks postoperative - 12 weeks postoperative - 6 months postoperative - 12 months postoperative
Primary Outcome Functional outcomes: The Arabic version of the disabilities of the arm, shoulder and hand questionnaire (DASH score) - 1 weeks postoperative - 4 weeks postoperative - 8 weeks postoperative - 12 weeks postoperative - 6 months postoperative
Secondary Outcome Assessment of Complications e.g. Infection, Deformity, Nonunion, loosening, stiffness 1 week postoperative - 4 weeks postoperative - 8 weeks postoperative - 12 weeks postoperative - 6 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suez Canal University Hospitals, Hand and microsurgery unit, Orthopedic surgery department 4.5 Km Ring Road Ismailia 41111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Governmental health insurance Ring Road, 5th Stage, El-Sheikh Zayed District Ismailia 41112 Egypt
Suez Canal University Hospitals, Orthopedic surgery department 4.5 Km Ring road Ismailia 41111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Asser Sallam, MD, PhD 4.5 Km Ring road Ismailia 41111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ahmed Metwally, MD 4.5 Km Ring road Ismailia 41111 Egypt
Mohamed Radwan, MD 4.5 Km Ring road Ismailia 41111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Asser Sallam assersallam@hotmail.com +20 109 5277212 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Lecturer and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Public Enquiries Mohamed Radwan radwanma@yahoo.com +201223326447 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Assist. Prof. and consultant of Orthopedic surgery and Trauma
Role Name Email Phone Street address
Scientific Enquiries Ahmed Metwally ammetwally@doctors.org.uk +201129871111 4.5 Km Ring Road, Suez Canal University Hospitals, Department of Orthopedic Surgery and Trauma
City Postal code Country Position/Affiliation
Ismailia 41111 Egypt Professor and consultant of Orthopedic surgery and Trauma
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information