Undisplaced Femoral Neck Fractures 2 Hansson Pins or 3 Pins Interlocked in Plate (Pinloc) Using RSA

NCT02699619 | Completed

• 1 other identifier: 2015/191/REK SO B
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures. A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically. The role of the Pinloc in clinical use remains unclear. Investigators are planning a randomized controlled trial on undisplaced femoral neck fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the Pinloc.

Conditions

Hip Fractures; Femoral Neck Fractures

Keywords

Undisplaced

Outcome Measures

Primary Outcomes (1)

• Change in 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.

  Up to 52 weeks

Secondary Outcomes (26)

• Perioperative blood loss

  1 week

• Time of surgery

  1 week

• Eq5d

  52 weeks

• Eq5d

  26 weeks

• Eq5d

  12 weeks

Study Arms (2)

2 Hansson pins without plate

ACTIVE COMPARATOR

Patients with undisplaced femoral neck fractures operated with 2 isolated Hansson pins.

Device: 2 Hansson pins

3 Hansson pins interlocked in a plate

ACTIVE COMPARATOR

Patients with undisplaced femoral neck fractures operated with 3 Hansson pins interlocked in plate (Pinloc).

Device: Pinloc

Interventions

Pinloc DEVICE

3 hook pins interlocked in plate.

Also known as: 3 hook pins interlocked in plate.

3 Hansson pins interlocked in a plate

2 Hansson pins DEVICE

2 isolated hook pins.(Without plate)

Also known as: 2 isolated hook pins.

2 Hansson pins without plate

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undisplaced femoral neck fractures
• able to walk independently, aids such as crutches or walker allowed
• able to consent
• fit for surgery with pins with or without plate

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 (i.e. cancer, COPD)

Sponsors & Collaborators

• Oslo University Hospital: lead
• Diakonhjemmet Hospital: collaborator

Study Sites (1)

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

Location

MeSH Terms

Conditions

Hip Fractures; Femoral Neck Fractures

Interventions

Bone Plates

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Frede Frihagen, PhD

  Oslo UH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, PhD

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: March 4, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

NO (1)