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

NCT02294747 | Completed

• 1 other identifier: 2014/475/REK SO B
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fractures; Trochanteric Fractures; Intertrochanteric Fractures

Outcome Measures

Primary Outcomes (1)

• Fracture displacement during healing measured with radiostereometry

  Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Total displacement from first reading to the reading showing maximum displacement is the main outcome.

  52 weeks

Secondary Outcomes (32)

• Perioperative blood loss

  1 week

• Time of surgery

  1 week

• Eq5d

  52 weeks

• Eq5d

  26 weeks

• Eq5d

  12 weeks

Other Outcomes (2)

• Reoperation for healing problems

  52 weeks

• Mortality

  52 weeks

Study Arms (2)

SHS without TSP

ACTIVE COMPARATOR

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

Device: Sliding Hip Screw without Trochanteric Stabilization Plate

SHS with TSP

ACTIVE COMPARATOR

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

Device: Sliding Hip Screw with Trochanteric Stabilization Plate

Interventions

Sliding Hip Screw with Trochanteric Stabilization Plate DEVICE

Also known as: Lateral Stabilizing Plate, Lateral Support Shield

SHS with TSP

Sliding Hip Screw without Trochanteric Stabilization Plate DEVICE

SHS without TSP

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Diakonhjemmet Hospital: collaborator

Study Sites (2)

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Frede Frihagen, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, PhD

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

NO (2)