Comparison of Patients Who Underwent Open and Minimally Invasive Fixation in Lateral Malleolar Fractures

NCT06753656 | Completed

• 1 other identifier: Ordu University CREC 2022/229
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the postoperative clinical, functional and radiological results of two different surgical methods, minimally invasive percutaneous plate osteosynthesis method and open reduction-internal fixation method, for lateral malleolus fractures in patients presenting with ankle fractures.

Conditions

Lateral Malleolus Fracture; Minimally Invasive Surgical Procedure; Postoperative Pain; Patient Discharge

Keywords

Lateral Malleolus Fractures; Minimally Invasive Surgery; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• Post operative Pain

  Patients were analysed for pain scores according to the numeric pain rating scale(NPRS) for the following periods

  Preoperatively and postoperatively 8th hour, 24th hour, 2nd week, 4th week, 3rd month, 6th month and 1st year

• Patient discharge time

  Preoperative, postoperative and total hospital stay and discharge times of the patients were recorded.

  Up to 12 months

Secondary Outcomes (2)

• The number and duration of fluoroscopy

  Postoperative 1st day

• Functional score

  Postoperatively 3rd month, 6th month and 1st year

Study Arms (2)

Minimally Invasive Surgery

EXPERIMENTAL

Closed reduction of the fracture without opening the fracture site

Procedure: Minimally Invasive Surgery

Open Surgery

ACTIVE COMPARATOR

open reduction of the fracture by opening the fracture site

Procedure: Open Surgery

Interventions

Open Surgery PROCEDURE

Open surgery technique: A longitudinal incision is made over the lateral malleolus, followed by sharp dissection down to the bone. The fracture is reduced under direct visualization and fixed with a plate and screws.

Open Surgery

Minimally Invasive Surgery PROCEDURE

Closed surgery technique: A 2-3 cm longitudinal incision is made distal to the lateral malleolus to allow for plate placement. A periosteal elevator is used to create a pathway for the plate. The fracture is reduced in a closed manner using reduction clamps, and the plate position is confirmed fluoroscopically. A second longitudinal incision is made proximal to the fracture, and the plate is temporarily fixed with Kirschner wires. The plate is then used as an external guide, with screws placed through mini-incisions. The fracture is fixed with the plate-screw system in a minimally invasive manner.

Minimally Invasive Surgery

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being a volunteer,
• closed distal fibular epiphysis,
• Lateral malleolus fractures operated for Weber type B or C fractures,
• patients with regular follow-up in outpatient clinic

You may not qualify if:

• open fractures
• fractures accompanied by pylon fractures,
• fractures accompanied by talus fractures,
• patients with a previous fracture/surgery of the same or another ankle,
• ankles accompanied by arthrosis,
• pathological fractures
• multitrauma or polytrauma patients,
• those with psychiatric or neurological diseases,
• illiterate patients,
• congenital or acquired deformity of the lower extremities
• Patients who could not be reduced intraoperatively closed and who underwent open surgery

Sponsors & Collaborators

• Giresun University: lead

Study Sites (1)

Giresun University Faculty of Medicine-Giresun Training and Research Hospital

Giresun, 28200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Fractures; Pain, Postoperative

Interventions

Conversion to Open Surgery; Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Surgical Procedures, Operative

Study Officials

• Kürşad Aytekin, M.D.

  Giresun University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be informed about both surgical techniques. Informed consent will be obtained. Accepting patients will be included in the study. Which group the patients are in will be masked. The surgical group in the follow-up will be explained. Outcome assessors were masked. Outcome assessors are senior surgeon and radiology doctor. Scoring will be taken by the senior surgeon. Radiological measurements will be performed at different times by the radiology doctor and the senior surgeon.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, Orthopaedics and Traumatology,

Model Details: Randomisation was performed before the first patient was included in the study. Patients were numbered according to the order of hospitalisation. According to these numbers, the surgical technique was applied to the patients according to the surgical technique group.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 31, 2024
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

TU (1)