K-Wires versus Titanium Miniplates in Unstable Phalangeal fractures

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201412000947268
• Date of registration: 26/11/2014
• Prospective Registration: Yes
• Primary sponsor: Asser Sallam, MD, PhD
• Public title: K-Wires versus Titanium Miniplates in Unstable Phalangeal fractures
• 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
• Date of first enrolment: 27/11/2014
• Target sample size: 40
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=947
• Study type: Interventional
• Study design: 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
• Phase: Not Applicable

Countries of recruitment

Egypt

Contacts

• Name: Mohamed Radwan
• Affiliation: Assist. Prof. and consultant of Orthopedic surgery and Trauma

• Name: Ahmed Metwally
• Affiliation: Professor and consultant of Orthopedic surgery and Trauma

Key inclusion & exclusion criteria

Inclusion criteria: - 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.
Exclusion criteria: - Patients with pathological fractures
- Finger joint stiffness
- Arthritic changes
- Open or intra-articular fracture
- Associated tendon injury

Age minimum: 6 Year(s)
Age maximum: 90 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Phalangeal fractures

Injury, Occupational Diseases, Poisoning
Surgery
Phalangeal fractures

Injury, Occupational Diseases, Poisoning

Surgery

Intervention(s)

Open reduction and internal fixation of phalangeal fractures with miniplates and screws

Percutaneous K-wires fixation of phalangeal fractures

Primary Outcome(s)

Radiological outcome: fracture healing and osteoarthritic changes to the finger joint. Bone union, which is defined as the disappearance of fracture lines.

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.

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.

Functional outcomes: The Arabic version of the disabilities of the arm, shoulder and hand questionnaire (DASH score)

Secondary Outcome(s)

Assessment of Complications e.g. Infection, Deformity, Nonunion, loosening, stiffness

Source(s) of Monetary Support

Suez Canal University Hospitals, Orthopedic surgery department

Governmental health insurance

Ethics review

Status: Approved
Approval date: 19/11/2014
Contact:

High Research Ethics Committee, Faculty of Medicine, Suez Canal University