Trochanteric Hip Fractures (AO A2) SHS With or Without Trochanteric Stabilizing Plate - Rct Using RSA

NCT ID: NCT02294747

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-12-31

Brief Summary

Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures as the other half). Trochanteric hip fractures are almost always treated surgically with internal fixation of the fracture. However there is a debate ongoing for what is the appropriate implant to use. For stable fracture patterns the evidence seems to be in favor of the sliding hip screw, but for the unstable fractures it is more unclear whether to use a intramedullary nail or sliding hip screw with or without a lateral support plate (TSP). The role of the TSP in clinical use remains unclear and very little has been published about this, but it is believed to be an important contributor of stability to the sliding hip screw construct. We are planning a randomized controlled trial on trochanteric hip fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the TSP.

Detailed Description

Trochanteric fractures represent about half of the hip fractures (with femoral neck fractures as the other half), and are almost always treated surgically with internal fixation of the fracture. However, there is an ongoing debate on what is the appropriate implant to use. For stable fracture patterns the evidence seems to be in favour of the sliding hip screw, whereas for the unstable fractures it is unclear whether an intramedullary nail or a sliding hip screw with or without a lateral support plate should be the implant of choice. A series of studies is now planned at Oslo University Hospital in collaboration with Diakonhjemmet Hospital in hope to further clarify this debate. The use of the lateral/trochanteric support plate (TSP) is widespread in some regions (e.g. Norway, Sweden and parts of Britain), but virtually never used other places. The role of the TSP remains unclear and very little has been published on it's use, even though it is believed to be an important contributor of stability to the sliding hip screw construct.

Trochanteric fractures are mainly caused by a direct trauma, i.e mainly a fall from own height in the elderly. The fractures are most often classified using the Müller AO classification or the Evans/Jensen, but several other classification systems also exist. The ideal classification system should be easily applicable, reliable, and aid in treatment decision making.

The treatment of trochanteric fractures comprise perioperative and operative modalities. The perioperative modalities consist among others of medical optimalization preoperatively, early rehabilitation and prevention of new fractures by treating osteoporosis and preventing new falls. The main scope of the current study will, however, be the operative modalities.

Surgery for trochanteric fractures is performed mainly with fracture reduction on a traction table and internal fixation, using either an intramedullary (IM) nail or a sliding hip screw (SHS), both available in various designs from different manufacturers. The latest Cochrane review did not conclude on which implant is the superior. However, among stable fractures there are less reoperations with the SHS, mainly due to peri-implant femoral fractures after operation with an IM nail that. The more unstable fractures, namely the reverse oblique and subtrochanteric fractures, may obtain better results using an intramedullary nail, probably due to less secondary dislocations with resulting varus deformity, shaft-medialization and shortening. The evidence for this is, however, weak and the role of the TSP remains unclear.

Radiostereometry (RSA) is the most precise and accurate method to measure motion in vivo between different segments in orthopaedic research. To do so, radio-opaque tantalum markers are implanted into the bone defining different segments. Stereoradiographs are performed over time to detect movement and monitor the healing (or non healing) process. This movement can be calculated both as translations and rotations. They are ideal to describe and compare the stability of fracture systems. RSA has been used successfully in earlier studies on fracture healing. Due to the high accuracy and precision, RSA yield reliable results with relatively small study-groups. We plan to use RSA to measure fracture dislocation and time to healing in our studies.

The study will be on the function of the trochanteric support plate and it´s ability to prevent secondary dislocation in AO 31 A2 fractures. We will utilize RSA for measurements during follow-up.

Conditions

Hip Fractures; Trochanteric Fractures; Intertrochanteric Fractures

Study Design

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

Study Groups

SHS without TSP

Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw without trochanteric stabilization plate.

Group Type: ACTIVE_COMPARATOR

Sliding Hip Screw without Trochanteric Stabilization Plate

Intervention Type: DEVICE

SHS with TSP

Patients with AO 31 A2 trochanteric fractures operated with sliding hip screw with trochanteric stabilization plate.

Group Type: ACTIVE_COMPARATOR

Sliding Hip Screw with Trochanteric Stabilization Plate

Intervention Type: DEVICE

Interventions

Sliding Hip Screw with Trochanteric Stabilization Plate

Intervention Type: DEVICE

Sliding Hip Screw without Trochanteric Stabilization Plate

Intervention Type: DEVICE

Other Intervention Names

Lateral Stabilizing Plate, Lateral Support Shield

Eligibility Criteria

Inclusion Criteria

• AO 31-A2
• able to walk independently, aids such as crutches or walker allowed
• able to consent
• fit for surgery with SHS with or without TSP

Exclusion Criteria

• not willing or able to attain follow up
• previous fracture or surgery with retained metal work in the same hip
• concomitant disease that will shorten life expectancy

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: collaborator

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Frede Frihagen

Consultant, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frede Frihagen, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Orthopedic Center, Ulleval University Hospital

Oslo, , Norway

Diakonhjemmet Hospital

Oslo, , Norway

Countries

Norway

Other Identifiers

2014/475/REK SO B

Identifier Type: -

Identifier Source: org_study_id