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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01380444




Registration number
NCT01380444
Ethics application status
Date submitted
20/06/2011
Date registered
27/06/2011
Date last updated
7/03/2019

Titles & IDs
Public title
Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation
Scientific title
A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip
Secondary ID [1] 0 0
96308751
Secondary ID [2] 0 0
14032012_INSITE_v2.0
Universal Trial Number (UTN)
Trial acronym
INSITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoral Neck Fractures 0 0
Intertrochanteric Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Gamma3 Intramedullary Nails (Stryker)
Treatment: Surgery - Sliding Hip Screws

Active comparator: 1 - Gamma3 Intramedullary Nails

Active comparator: 2 - Sliding Hip Screws


Treatment: Surgery: Gamma3 Intramedullary Nails (Stryker)
The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.

Treatment: Surgery: Sliding Hip Screws
The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Health Related Quality of Life
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [1] 0 0
Health Related Quality of Life
Timepoint [1] 0 0
Up to 104 weeks
Secondary outcome [2] 0 0
Fracture healing rates
Timepoint [2] 0 0
Up to 104 weeks
Secondary outcome [3] 0 0
Fracture-related adverse events
Timepoint [3] 0 0
Up to 104 weeks
Secondary outcome [4] 0 0
Revision surgery rates
Timepoint [4] 0 0
Up to 104 weeks

Eligibility
Key inclusion criteria
1. Adult men or women aged 18 years and older (with no upper age limit).
2. An intertrochanteric fracture (stable or unstable), AO Type 31-A1 or 31-A2, confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
3. Low energy fracture (defined as a fall from standing height).
4. No other major trauma.
5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
6. Anticipated medical optimization of the patient for operative fixation of the proximal femur.
7. Operative treatment within 7 days after the trauma.(Operative treatment should take place as soon as possible as permitted by each institution's standard of care.)
8. Provision of informed consent by patient or proxy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Associated major injuries of the lower extremity (i.e., ipsilateral and/or contralateral fractures of the foot, ankle, tibia, fibula, or knee; dislocations of the ankle, knee, or hip).
2. Retained hardware around the affected proximal femur.
3. Infection around the proximal femur (i.e., soft tissue or bone).
4. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
5. Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
6. Patients with a subtrochanteric fracture.
7. Patients with a pathologic fracture.
8. Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3.
9. Obesity in the judgment of the attending surgeon.
10. Off-label use of the implant.
11. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year).
12. Likely problems, in the judgment of the Site Investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
13. Patient is enrolled in another ongoing drug or surgical intervention trial.
14. If the attending surgeon believes that there is another reason to exclude this patient from INSITE. This reason will be documented on the case report forms (CRFs).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
880
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
3039 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Canada
State/province [6] 0 0
Manitoba
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
China
State/province [10] 0 0
Zhejiang
Country [11] 0 0
Colombia
State/province [11] 0 0
Antioquia
Country [12] 0 0
Colombia
State/province [12] 0 0
Cundinamarca
Country [13] 0 0
Denmark
State/province [13] 0 0
Aarhus
Country [14] 0 0
Germany
State/province [14] 0 0
Lübeck
Country [15] 0 0
Germany
State/province [15] 0 0
Stuttgart
Country [16] 0 0
Japan
State/province [16] 0 0
Ibaraki
Country [17] 0 0
Netherlands
State/province [17] 0 0
Amsterdam
Country [18] 0 0
Norway
State/province [18] 0 0
Alesund
Country [19] 0 0
South Africa
State/province [19] 0 0
Parktown
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Bristol
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Liverpool
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Reading
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Stryker Trauma and Extremities
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Global Research Solutions
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQuol-5D at 52 weeks in individuals with trochanteric fractures. Secondary outcomes include revision surgery rates, fracture healing rates, fracture related adverse events, and health-related quality of life, including the Parker mobility score and Harris Hip Score.
Trial website
https://clinicaltrials.gov/study/NCT01380444
Trial related presentations / publications
Ahrengart L, Tornkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlstrom P, Honkonen S, Lindgren U. A randomized study of the compression hip screw and Gamma nail in 426 fractures. Clin Orthop Relat Res. 2002 Aug;(401):209-22. doi: 10.1097/00003086-200208000-00024.
Bhandari M, Schemitsch E, Jonsson A, Zlowodzki M, Haidukewych GJ. Gamma nails revisited: gamma nails versus compression hip screws in the management of intertrochanteric fractures of the hip: a meta-analysis. J Orthop Trauma. 2009 Jul;23(6):460-4. doi: 10.1097/BOT.0b013e318162f67f.
Parker MJ, Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD000093. doi: 10.1002/14651858.CD000093.pub4.
Public notes

Contacts
Principal investigator
Name 0 0
Mohit Bhandari, MD, PhD, FRCSC
Address 0 0
Global Research Solutions
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01380444