Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation

NCT01380444 | Completed

• 2 other identifiers: 14032012_INSITE_v2.096308751
• Study Type: interventional
• Target: 880
• Locations: 12 countries
• Sites: 26

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.

Conditions

Femoral Neck Fractures; Intertrochanteric Fracture

Keywords

Intertrochanteric fracture; Gamma3 intramedullary nail; Sliding hip screw

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health Related Quality of Life

  Up to 104 weeks

• Fracture healing rates

  Up to 104 weeks

• Fracture-related adverse events

  Up to 104 weeks

• Revision surgery rates

  Up to 104 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Gamma3 Intramedullary Nails

Procedure: Gamma3 Intramedullary Nails (Stryker)

2

ACTIVE COMPARATOR

Sliding Hip Screws

Procedure: Sliding Hip Screws

Interventions

Gamma3 Intramedullary Nails (Stryker) 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.

Also known as: Gamma Nail, Gamma3 Nail, Intramedullary Nail (IM Nail)

1

Sliding Hip Screws 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.

Also known as: Sliding Hip Screw (SHS), Dynamic Hip Screw (DHS), Compression Screw and Side Plate

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men or women aged 18 years and older (with no upper age limit).
• 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).
• Low energy fracture (defined as a fall from standing height).
• No other major trauma.
• Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
• Anticipated medical optimization of the patient for operative fixation of the proximal femur.
• 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.)
• Provision of informed consent by patient or proxy.

You may not qualify if:

• 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).
• Retained hardware around the affected proximal femur.
• Infection around the proximal femur (i.e., soft tissue or bone).
• Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy, or osteomalacia).
• Patients with Parkinson's disease severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
• Patients with a subtrochanteric fracture.
• Patients with a pathologic fracture.
• Patients with a reverse oblique fracture pattern, fracture AO Type 31-A3.
• Obesity in the judgment of the attending surgeon.
• Off-label use of the implant.
• Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., EQ-5D at 1 year).
• 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.
• Patient is enrolled in another ongoing drug or surgical intervention trial.
• 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).

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead
• Global Research Solutions: collaborator

Study Sites (26)

Community Regional Medical Center

Fresno, California, 93721, United States

Location

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Scott&White Memorial Hospital

Temple, Texas, 76508, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3039, Australia

Location

Health Sciences Centre Winnipeg

Winnipeg, Manitoba, R3A 1R9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

2nd Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Clinica El Rosario Sede El Tesoro

Medellín, Antioquia, Colombia

Location

Hospital Universitario Santa Clara

Bogotá, Cundinamarca, Colombia

Location

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Robert-Bosch-Krankenhaus

Stuttgart, 70376, Germany

Location

Tsukuba Medical Center

Tsukuba, Ibaraki, 305-8558, Japan

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091, Netherlands

Location

Helse Sunnmore Alesund Sjukehus

Ålesund, 6026, Norway

Location

Charlotte Maxeke Johannesburg Academic Hospital

Parktown, 2193, South Africa

Location

Frenchay Hospital

Bristol, BS16 1LE, United Kingdom

Location

The Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

The Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 12151898 BACKGROUND

• 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.

  PMID: 19550235 BACKGROUND

• 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.

  PMID: 18646058 BACKGROUND

• 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.

  PMID: 37278998 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures

Interventions

Fracture Fixation, Intramedullary

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation, Internal; Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mohit Bhandari, MD, PhD, FRCSC

  Global Research Solutions

  PRINCIPAL INVESTIGATOR

• Georgia Mitchell

  Stryker Trauma and Extremities

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: June 27, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 7, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1); CN (3); DE (2); ZA (1); US (7); GB (4); NO (1); CA (2); AU (1); DK (1); CO (2); NL (1)