Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

Not Applicable

Completed

• Conditions: Femoral Neck Fractures; Intertrochanteric Fracture
• Interventions: Procedure: Sliding Hip Screws; Procedure: Gamma3 Intramedullary Nails (Stryker)

• Registration Number: NCT01380444
• Lead Sponsor: Stryker Trauma and Extremities

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Study Start: 2011-12
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 880

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Sliding Hip Screws	Sliding Hip Screws
1	Gamma3 Intramedullary Nails (Stryker)	Gamma3 Intramedullary Nails

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life	Up to 104 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Fracture healing rates	Up to 104 weeks	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.
Health Related Quality of Life	Up to 104 weeks	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.
Revision surgery rates	Up to 104 weeks	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.
Fracture-related adverse events	Up to 104 weeks	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).

Trial Locations

Locations (26)

Inova Fairfax Hospital; 🇺🇸 Falls Church, Virginia, United States

Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

The Royal Liverpool University Hospital; 🇬🇧 Liverpool, United Kingdom

Tsukuba Medical Center; 🇯🇵 Tsukuba City, Ibaraki, Japan

Charlotte Maxeke Johannesburg Academic Hospital; 🇿🇦 Parktown, South Africa

Universitätsklinikum Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Germany

The Royal Berkshire Hospital; 🇬🇧 Reading, United Kingdom

Frenchay Hospital; 🇬🇧 Bristol, United Kingdom

Health Sciences Centre Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Community Regional Medical Center; 🇺🇸 Fresno, California, United States

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States

Scott&White Memorial Hospital; 🇺🇸 Temple, Texas, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

2nd Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Clinica El Rosario Sede El Tesoro; 🇨🇴 Medellin, Antioquia, Colombia

Hospital Universitario Santa Clara; 🇨🇴 Bogotá, Cundinamarca, Colombia

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Helse Sunnmore Alesund Sjukehus; 🇳🇴 Alesund, Norway

The Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom