- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04240743
Fixation Methods of Basicervical Fractures
Comparison of Intramedullary and Extramedullary Fixation of Basicervical Fractures of the Femur in the Elderly: a Prospective, Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approval for this prospective randomized study was granted by the Local Ethics Review Board and all procedures were performed in accordance with the ethical standards of the Declaration of Helsinki (1964). Patients with a basicervical femur fracture were identified on admission to the Emergency Department of our tertiary hospital from January 2016 to January 2018. Patients with scheduled surgery who met the inclusion criteria and provided written informed consent were included in the study.
Patients were randomly allocated to a study group by permuted blocks of randomly mixed sizes and stratification according to the type of surgery (CMN or SHS). Randomization was applied using pre-prepared randomization cards, which were placed in opaque sealed envelopes and given to the surgeons to open just prior to surgery, and the designated procedure was then performed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- basicervical fracture,
- age of ≥65 year,
- an isolated fracture,
- the ability to walk independently (with or without an aid) prior to fracture,
- a fracture that had occurred less than one week prior to admission.
Exclusion Criteria:
- history of ipsilateral femoral fracture,
- a fracture due to malignancy,
- limited life expectancy due to medical comorbidities,
- any contraindication to surgery,
- diagnosed dementia,
- any other traumatic fracture on admission.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: cephalomedullary nail
Cephalomedullary nails was inserted and fixed to the femoral head.
In this study, all patients were treated with short nails (Profin®, TST).
|
For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation.
A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter.
The entry point of the greater trochanter and proximal medullary canal were reamed.
The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw.
The cephalomedullary nail was then locked distally using a guide arm.
These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.
For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur.
Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire.
A side plate with three holes was then attached to the hip screw.
|
Active Comparator: sliding hip screw
Sliding hip screws was inserted and fixed to the femoral head.
In this study, all patients were treated with a side plate with three holes (DHS plate, TST).
|
For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation.
A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter.
The entry point of the greater trochanter and proximal medullary canal were reamed.
The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw.
The cephalomedullary nail was then locked distally using a guide arm.
These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.
For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur.
Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire.
A side plate with three holes was then attached to the hip screw.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mobility score
Time Frame: 12 months
|
Functional outcome was assessed by the mobility score of Parker and Palmer (Parker MJ, Palmer CR (1993) A new mobility score for predicting mortality after hip fracture.
J Bone Joint Surg Br 75: 797-798), which uses a nine-point scale.
|
12 months
|
Harris hip score
Time Frame: 12 months
|
Hip function was rated with Harris Hip Score.
The score has a maximum of 100 points (best possible function), covering pain (1 item, 0-44 points), function and activities (7 items, 0-47 points), and range of motion and absence of deformity (3 items, 0-9 points).
|
12 months
|
modified Barthel index
Time Frame: 12 months
|
Barthel Index (Mahoney FI, Barthel DW (1965) Functional evaluation: the Barthel Index.
A simple index of independence useful in scoring improvement in the rehabilitation of the chronically ill.
Md State Med J 13:61-65), which measures the level of functional independence for 10 activities of daily living and ranges from 0 to 100.
|
12 months
|
the tip-apex distance
Time Frame: 12 months
|
It uses a numerical value (the distance between tip of screw and subchondral area) to show placement of the screw in the head: higher values indicating higher likelihood of fixation failure by extrusion of the screw.
|
12 months
|
fracture settling
Time Frame: 12 months
|
It uses a numerical value to show placement of shortening of the fractured femoral neck in time
|
12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/514/74/7
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hip Fractures
-
Smith & Nephew, Inc.Terminated
-
Texas Tech University Health Sciences Center, El...CompletedHip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)United States
-
Carilion ClinicCompleted
-
FH ORTHORecruitingHip Fractures | Hip DiseaseFrance
-
Zhenjiang First People's HospitalCompletedHip Fractures | Hip DiseaseChina
-
Bayside HealthCompleted
-
Oslo University HospitalDiakonhjemmet HospitalCompletedHip Fractures | Trochanteric Fractures | Intertrochanteric FracturesNorway
-
Tel-Aviv Sourasky Medical CenterUnknownIntertrochanteric Fractures of the HipIsrael
-
University of Missouri-ColumbiaUniversity of Alabama at Birmingham; Medical College of Wisconsin; University...CompletedHip Fractures | Pelvic Fractures | Acetabular FracturesUnited States
-
Rabin Medical CenterUnknown
Clinical Trials on cephalomedullary nail
-
University General Hospital of PatrasRecruitingPertrochanteric Fracture of Femur, ClosedGreece
-
Mayo ClinicCompletedPertrochanteric Hip FractureUnited States
-
Milton S. Hershey Medical CenterWithdrawnPertrochanteric Fracture of Femur, Closed
-
Montefiore Medical CenterJacobi Medical CenterWithdrawnPain, Postoperative | Analgesia | Hip Fractures | Opioid UseUnited States
-
Assiut UniversityRecruiting
-
DePuy Synthes Products, Inc.RecruitingFemoral Fractures | Tibial FracturesUnited States
-
Taipei Medical University WanFang HospitalUnknown
-
Stryker Trauma GmbHGlobal Research Solutions; Stryker OsteosynthesisCompletedFemoral Neck Fractures | Intertrochanteric FractureSweden, Denmark, Canada
-
Paragon 28CompletedBunion | Hallux Valgus | ArthrodesisUnited States
-
Florida Orthopaedic InstituteUnknownHip Fracture | Intertrochanteric FractureUnited States