Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

Femoral Neck Fractures Clinical Trial

— INSITE  

Official title:

A Multi-Center Randomized Controlled Trial of Intramedullary Nails Versus Sliding Hip Screws in the Management of Intertrochanteric Fractures of the Hip

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380444
• Other study ID #: 14032012_INSITE_v2.0
• Secondary ID: 96308751
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: March 2017

Study information

• Verified date: March 2019
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hip fractures are becoming a more prevalent issue worldwide, leading to profound morbidity, and in some cases, mortality. Currently the most common method of surgical treatment includes the use of a sliding hip screw over a Gamma intramedullary nail, but there is conflicting evidence regarding which device has a lower revision surgery rate and complication rate. Recent improvements in implant design of the Gamma3 nail, demonstrating decreased rates of femoral shaft fractures and improved function, provide compelling rationale for the conduct of a large, definitive trial.

This trial is a definitive, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained a trochanteric fracture; the Gamma3 intramedullary nail or the sliding hip screw. Clinical assessments will occur at the time of hospital admission, post-surgery, 13 weeks, 26 weeks, 52 weeks, and 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 880
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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).

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fracture

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital	Parkville	Victoria
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Health Sciences Centre Winnipeg	Winnipeg	Manitoba
China	Chaoyang Hospital	Beijing	Beijing
China	2nd Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Sixth People's Hospital	Shanghai	Shanghai
Colombia	Hospital Universitario Santa Clara	Bogotá	Cundinamarca
Colombia	Clinica El Rosario Sede El Tesoro	Medellin	Antioquia
Denmark	Aarhus University Hospital	Aarhus
Germany	Universitätsklinikum Schleswig-Holstein, Campus Lübeck	Lübeck
Germany	Robert-Bosch-Krankenhaus	Stuttgart
Japan	Tsukuba Medical Center	Tsukuba City	Ibaraki
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Norway	Helse Sunnmore Alesund Sjukehus	Alesund
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Parktown
United Kingdom	Frenchay Hospital	Bristol
United Kingdom	The Royal Liverpool University Hospital	Liverpool
United Kingdom	The Royal Berkshire Hospital	Reading
United Kingdom	Southampton General Hospital	Southampton
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Community Regional Medical Center	Fresno	California
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	San Francisco General Hospital	San Francisco	California
United States	Scott&White Memorial Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Stryker Trauma GmbH	Global Research Solutions

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Colombia,  Denmark,  Germany,  Japan,  Netherlands,  Norway,  South Africa,  United Kingdom, 

References & Publications (3)

Ahrengart L, Törnkvist H, Fornander P, Thorngren KG, Pasanen L, Wahlström 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. — View Citation

Bhandari M, Schemitsch E, Jönsson 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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2010;(9):CD000093. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life	To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured by the EuroQol-5D at 52 weeks in individuals with trochanteric fractures.	Up to 104 weeks
Secondary	Health Related Quality of Life	To assess the impact of Gamma3 intramedullary nails versus sliding hip screws on health-related quality of life as measured with the Parker mobility score and the Harris Hip Score.	Up to 104 weeks
Secondary	Fracture healing rates	A fracture is to be considered healed when there is obliteration of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior and lateral (or oblique) radiographs.	Up to 104 weeks
Secondary	Fracture-related adverse events	Including mortality, femoral shaft fracture, avascular necrosis (although rare in trochanteric fractures), nonunion, malunion (shortening, varus deformity, valgus deformity and rotational malunion), implant breakage or failure, and infection (i.e., superficial and deep).	Up to 104 weeks
Secondary	Revision surgery rates	Any unplanned surgery after the initial fixation to promote fracture healing (non-union), relieve pain (avascular necrosis, early or late implant failure), treat infection, or improve function will be considered a study event.	Up to 104 weeks