Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures
Primary Purpose
Hip Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.
Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip fractures, Intertrochanteric fractures, Cephalomedullary Nails, Cut-out, Cut through
Eligibility Criteria
Inclusion Criteria:
- Low Energy Mechanism
- Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
Exclusion Criteria:
- A fracture due to malignancy
- Previous contralateral fracture
- Inability to walk before the fracture
- An inability to comply with rehabilitation
- Follow-up of less than 6 months
Sites / Locations
- Instituto TraumatologicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
lag screw with dynamic mode
lag screw with static mode
Arm Description
Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
Outcomes
Primary Outcome Measures
Implant failure
Rate of cut out , cut through.
Secondary Outcome Measures
Complications
Rate of Infection and Non Union.
Offset
Changes in femoral offset
Full Information
NCT ID
NCT04441723
First Posted
June 18, 2020
Last Updated
June 22, 2020
Sponsor
Instituto Traumatologico Dr. Teodoro Gebauer Weisser
1. Study Identification
Unique Protocol Identification Number
NCT04441723
Brief Title
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures
Official Title
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Peritrochanteric Fragility Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Traumatologico Dr. Teodoro Gebauer Weisser
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to compare the failure rate between two modes of fixing the lag screw of the cephalomedullary nail.
The sample studied will be patients who have been diagnosed with a fragility intertrochanteric fracture.
Investigators hypothesis is that the dynamic mode will have a lower failure rate compared to the static mode.
Detailed Description
Intertrochanteric fragility fractures are one of the most frequent fractures in the elderly . They produce great disability and complications in our patients and they are recognized worldwide as a major public health problem.
The treatment that presents the best results is surgical treatment, since it reduces the mortality of the patients and allows early loading . Thus, avoids secondary complications to the prostration state such as pneumonia, bedsores, pulmonary embolisms, among others.
Currently, the treatment that has shown the best clinical and biomechanical results is osteosynthesis with a cephalomedullary nail, which despite having good results is not free from complications such as implant failure, loss of femoral offset.
Changes are constantly made in the design and surgical techniques of these implants in order to decrease the rate of complications.
This study will particularly assess whether there is any difference in the complication rate between dynamic versus static lag screw modes.
Biomechanical studies that compare these two lag screw modes show that axial and lateral stiffness of the femur-nail construction is greater in static mode than in dynamic modes and the torsional stiffness is greater in dynamic mode than in static modes.
There are no studies comparing the clinical results of these two variants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip fractures, Intertrochanteric fractures, Cephalomedullary Nails, Cut-out, Cut through
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lag screw with dynamic mode
Arm Type
Active Comparator
Arm Description
Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
Arm Title
lag screw with static mode
Arm Type
Active Comparator
Arm Description
Device: Gamma 3 nail whit lag screw on dynamic mode Surgical stabilization of intertrochanteric hip fractures using two different lag screw modes
Intervention Type
Device
Intervention Name(s)
Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.
Intervention Description
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation
Intervention Type
Device
Intervention Name(s)
Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.
Intervention Description
Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation
Primary Outcome Measure Information:
Title
Implant failure
Description
Rate of cut out , cut through.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Complications
Description
Rate of Infection and Non Union.
Time Frame
3 weeks, 3 months , 6 months
Title
Offset
Description
Changes in femoral offset
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low Energy Mechanism
Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)
Exclusion Criteria:
A fracture due to malignancy
Previous contralateral fracture
Inability to walk before the fracture
An inability to comply with rehabilitation
Follow-up of less than 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pablo Suarez, MD
Phone
+56961572181
Email
pablosuarez088@gmail.com
Facility Information:
Facility Name
Instituto Traumatologico
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Suarez, MD
Phone
+56961572181
Email
pablosuarez088@gmail.com
First Name & Middle Initial & Last Name & Degree
Enrique Cifuentes, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22439235
Citation
Kuzyk PR, Shah S, Zdero R, Olsen M, Waddell JP, Schemitsch EH. A biomechanical comparison of static versus dynamic lag screw modes for cephalomedullary nails used to fix unstable peritrochanteric fractures. J Trauma Acute Care Surg. 2012 Feb;72(2):E65-70. doi: 10.1097/ta.0b013e3182170823.
Results Reference
background
PubMed Identifier
8020229
Citation
Mahomed N, Harrington I, Kellam J, Maistrelli G, Hearn T, Vroemen J. Biomechanical analysis of the Gamma nail and sliding hip screw. Clin Orthop Relat Res. 1994 Jul;(304):280-8.
Results Reference
background
PubMed Identifier
29166235
Citation
Bhandari M, Swiontkowski M. Management of Acute Hip Fracture. N Engl J Med. 2017 Nov 23;377(21):2053-2062. doi: 10.1056/NEJMcp1611090. No abstract available.
Results Reference
background
Learn more about this trial
Comparison of Dynamic Versus Static Lag Screw Modes for Cephalomedullary Nails Used to Fix Intertrochanteric Fragility Fractures
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