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

Hip Fractures Clinical Trial

Official title:

Undisplaced Femoral Neck Fractures Treated With 2 Hansson Pins Without Plate or 3 Hansson Pins Interlocked in a Plate (Pinloc) - A Randomized Controlled Trial Using Radiostereometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699619
• Other study ID #: 2015/191/REK SO B
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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 Pinloc has been introduced in some regions (e.g. Norway, Sweden and Japan). The role of the Pinloc 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 fixation.

Femoral neck fractures are mainly caused by a fall from own height in the elderly. The fractures are most often classified as displaced or not, using the simplified Garden classification. Several other classification systems also exist, but these have not been shown to be of reliable clinical usefulness. The ideal classification system should be easily applicable, reliable, and aid in treatment decision making and prognosis.

The treatment of femoral neck 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 undsiplaced femoral neck fractures is performed mainly with internal fixation on a traction table, using either screws, pins or a sliding hip screw (SHS), available in various designs from different manufacturers. The latest Cochrane review did not conclude on which implant is the superior.

Radiostereometry (RSA) is the most precise and accurate method to measure motion in vivo between different segments in orthopaedic research. To do so, radioopaque 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. Investigators plan to use RSA to measure fracture dislocation and time to healing in our studies. The study will be on the function of the Pinloc and it´s ability to prevent secondary dislocation in undisplaced femoral neck fractures. Investigators will utilize RSA for measurements during follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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

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 (i.e. cancer, COPD)

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Device:
• Pinloc
3 hook pins interlocked in plate.
• 2 Hansson pins
2 isolated hook pins.(Without plate)

Locations

Country	Name	City	State
Norway	Orthopedic Center, Ulleval University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perioperative blood loss		1 week
Secondary	Time of surgery		1 week
Secondary	Eq5d	Health Related Quality of Life (Hrqol).	52 weeks
Secondary	Eq5d	Hrqol.	26 weeks
Secondary	Eq5d	Hrqol.	12 weeks
Secondary	Eq5d	Hrqol.	4 weeks
Secondary	Change in time to union as measured by RSA (cessation of motion) and radiographs	When RSA shows that no motion has happened between two time points the fracture will be regarded as healed at the former time point.	Will be examined at 4, 12, 26 and 52 weeks
Secondary	Change in time to union as measured by plain radiographs and clinical findings	Composite endpoint: Healing defined by obliteration of fracture line radiographically and pain free weight bearing (except lateral pain from hardware), when this occurs the fracture will be considered healed.	Will be examined at 4,12, 26 and 52 weeks
Secondary	Harris Hip Score	Will be examined at 4,12, 26 and 52 weeks	Up to 52 weeks
Secondary	Postoperative pain (NRS) while in hospital	Pain at mobilization (NRS) at discharge	1 week
Secondary	Timed Up and Go test	Tug	4 weeks
Secondary	Timed Up and Go test	Tug	12 weeks
Secondary	Timed Up and Go test	Tug	26 weeks
Secondary	Timed Up and Go test	Tug	52 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	4 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	12 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	26 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	52 weeks
Secondary	Satisfaction with operated hip (NRS)	NRS	4 weeks
Secondary	Satisfaction with operated hip (NRS)	NRS	12 weeks
Secondary	Satisfaction with operated hip (NRS)	NRS	26 weeks
Secondary	Satisfaction with operated hip (NRS)	NRS	52 weeks
Secondary	Motion during healing as measured by radiostereometry.	Will be measured by RSA postoperatively, before discharge and after 4, 12, 24 and 52 weeks.	Up to 52 weeks
Secondary	Motion during healing as measured by plain radiographs.	Will be measured by RSA postoperatively, before discharge and after 4,12, 24 and 52 weeks.	Up to 52 weeks
Secondary	Reoperation for healing problems	Any additional surgery addressing healing problems or hardware failure	52 weeks
Secondary	Mortality	Any reason	52 weeks