Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

NCT ID: NCT01380444

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-03-31

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.

Conditions

Femoral Neck Fractures; Intertrochanteric Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Gamma3 Intramedullary Nails

Group Type: ACTIVE_COMPARATOR

Gamma3 Intramedullary Nails (Stryker)

Intervention Type: PROCEDURE

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.

2

Sliding Hip Screws

Group Type: ACTIVE_COMPARATOR

Sliding Hip Screws

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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 Type: PROCEDURE

Other Intervention Names

Gamma Nail; Gamma3 Nail; Intramedullary Nail (IM Nail); Sliding Hip Screw (SHS); Dynamic Hip Screw (DHS); Compression Screw and Side Plate

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Global Research Solutions

INDUSTRY

Sponsor Role: collaborator

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohit Bhandari, MD, PhD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Global Research Solutions

Georgia Mitchell

Role: STUDY_DIRECTOR

Stryker Trauma and Extremities

Locations

Community Regional Medical Center

Fresno, California, United States

San Francisco General Hospital

San Francisco, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Scott&White Memorial Hospital

Temple, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Chaoyang Hospital

Beijing, Beijing Municipality, China

Sixth People's Hospital

Shanghai, Shanghai Municipality, China

2nd Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Clinica El Rosario Sede El Tesoro

Medellín, Antioquia, Colombia

Hospital Universitario Santa Clara

Bogotá, Cundinamarca, Colombia

Aarhus University Hospital

Aarhus, , Denmark

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, , Germany

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Tsukuba Medical Center

Tsukuba, Ibaraki, Japan

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Helse Sunnmore Alesund Sjukehus

Ålesund, , Norway

Charlotte Maxeke Johannesburg Academic Hospital

Parktown, , South Africa

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 Kingdom

Countries

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

References

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.

Reference Type: BACKGROUND

PMID: 12151898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19550235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18646058 (View on PubMed)

Schemitsch EH, Nowak LL, Schulz AP, Brink O, Poolman RW, Mehta S, Stengel D, Zhang CQ, Martinez S, Kinner B, Chesser TJS, Bhandari M; INSITE Investigators. Intramedullary Nailing vs Sliding Hip Screw in Trochanteric Fracture Management: The INSITE Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2317164. doi: 10.1001/jamanetworkopen.2023.17164.

Reference Type: DERIVED

PMID: 37278998 (View on PubMed)

Other Identifiers

96308751

Identifier Type: REGISTRY

Identifier Source: secondary_id

14032012_INSITE_v2.0

Identifier Type: -

Identifier Source: org_study_id