Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03367169
Other study ID # CHU-368
Secondary ID 2017-A01735-48
Status Terminated
Phase N/A
First received
Last updated
Start date November 23, 2017
Est. completion date April 26, 2024

Study information

Verified date April 2024
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation. The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.


Description:

Several surgical techniques exist and among plate osteosynthesis, there is a minimally invasive method and the open reduction method. Investigators think that the minimally invasive method with intern plate is more efficient than the open reduction method. These techniques may better preserve perifracture soft tissues, hematoma. It may lead to a smaller muscle detachment. The minimally invasive technique allows a more efficient vascularization of the fracture site, what would increase bone healing and the functional prognosis of tibial pilon lesions. It's all these issues investigators would like to assess with a randomized study.


Recruitment information / eligibility

Status Terminated
Enrollment 54
Est. completion date April 26, 2024
Est. primary completion date April 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - More than 18-year-old with opened or closed pilon fracture Cauchoix type 1, - signed patient consent Exclusion Criteria: - Open pilon fracture cauchoix type 2 or 3, - infection of the operating site, - previous osseous disease - patient who are unwilling or unable to give consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
minimally invasive method
type of surgical technique
open reduction method
type of surgical technique

Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healing Measure of the duration of the bandage with index form of follow-up the state cutaneous of the wound. This measure was a number. at 45 days
Secondary AOFAS clinical score American Orthopedic Foot and Ankle Society was a standard method of reporting clinical status of the ankle and foot. The systems incorporate both subjective and objective factors into numerical scales to describe function, alignment, and pain. The score varies between 0 and 100, more the value is better brought up is the score pre op, 45 days, 3, 6 and 12 months
Secondary Nach mazur and al score The Nach mazur grading system uses 100 points to assess pain, function while wearing shoes and the range of ankle movement. The maximum score a patient with a solid ankle fusion. pre op 45 days, 3, 6 and 12 months
Secondary The Foot & Ankle Disability Index The Foot and Ankle Disability Index (FADI) was designed to assess functional limitations related to foot and ankle conditions. Subjective reports of function are classified as generic or specific measures, which include condition-specific, population-specific, and patient-specific instruments. The FADI have a total point value of 100 points, more the value is better brought up is the score pre op 45 days, 3, 6 and 12 months
Secondary Pain THE VISUAL SIMILAR SCALE is auto-completed. For the intensity of pain, the scale varies between " no pain " (the score of 0) and " the pain so badly as he could be " or " the worst conceivable pain " (the score of 10) pre op 45 days, 3, 6 and 12 months
Secondary Complications list of the complications pre op 45 days, 3, 6 and 12 months
Secondary Radiologic evaluation Radiologic evaluation pre op 45 days, 3, 6 and 12 months
See also
  Status Clinical Trial Phase
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A
Completed NCT00152321 - Strategies Targeting Osteoporosis to Prevent Recurrent Fractures N/A
Completed NCT00235404 - Randomized Controlled Trial of Health Care to Elderly Patients. N/A
Completed NCT01127711 - Cohort of Swedish Men N/A
Completed NCT00060970 - Evaluating Muscle Function After Ankle Surgery N/A
Completed NCT02576730 - Functional Outcome Assessment After (Calcaneal) Trauma Surgey N/A
Completed NCT02074969 - Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures N/A
Completed NCT00767780 - The Effect of a New Biomechanical Device N/A
Withdrawn NCT00355420 - Evaluation of the Change in Length of the Leg in Children After Treatment of Femur Fractures. Phase 2
Completed NCT00129142 - Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy Phase 3
Active, not recruiting NCT01452243 - Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial Phase 3
Completed NCT00545350 - Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study N/A
Terminated NCT00387686 - A Phase 2/3 Multicenter, Controlled Trial Of rhBMP-2/CPM In Tibial Fractures Phase 2/Phase 3
Completed NCT02292316 - Falls With Fracture : Role of Cognitive Disorders and Comparison With Bone Fragility N/A
Completed NCT01136616 - CT Analysis of Structural Buttresses in the Traumatised Nose Phase 2
Completed NCT02090972 - The Impact of Opioids in Fractures - a Case Control Study N/A
Recruiting NCT02237040 - A New Treatment Protocol for Paediatric Mandibular Condylar Fractures N/A
Completed NCT00872105 - Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle N/A
Completed NCT00652548 - Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients N/A
Completed NCT00079521 - Therapeutic Touch for Wrist Fractures in Postmenopausal Women Phase 2