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

Hip Fractures Clinical Trial

Official title:

Trochanteric Hip Fractures (AO A2) Treated With Sliding Hip Screw With or Without Trochanteric Stabilizing Plate - a Randomized Controlled Trial Using Radiostereometry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294747
• Other study ID #: 2014/475/REK SO B
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fractures
• Trochanteric Fractures

Intervention

Device:
• Sliding Hip Screw with Trochanteric Stabilization Plate

• Sliding Hip Screw without Trochanteric Stabilization Plate

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo
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
Other	Reoperation for healing problems	Any additional surgery addressing healing problems or hardware failure	52 weeks
Other	Mortality	Any reason	52 weeks
Primary	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	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.	8 weeks
Secondary	Eq5d	Hrqol.	4 weeks
Secondary	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, 8, 12, 26 and 52 weeks
Secondary	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, 8, 12, 26 and 52 weeks
Secondary	Harris Hip Score	Will be examined at 4, 8, 12, 26 and 52 weeks	52 weeks
Secondary	Harris Hip Score	Will be examined at 4, 8, 12, 26 and 52 weeks	26 weeks
Secondary	Harris Hip Score	Will be examined at 4, 8, 12, 26 and 52 weeks	12 weeks
Secondary	Harris Hip Score	Will be examined at 4, 8, 12, 26 and 52 weeks	8 weeks
Secondary	Harris Hip Score	Will be examined at 4, 8, 12, 26 and 52 weeks	4 weeks
Secondary	Postoperative pain (NRS) while in hospital	Pain at mobilization (NRS) at discharge	1 week
Secondary	Timed Up and Go (Tug) test		4 weeks
Secondary	Timed Up and Go (Tug) test		8 weeks
Secondary	Timed Up and Go (Tug) test		12 weeks
Secondary	Timed Up and Go (Tug) test		26 weeks
Secondary	Timed Up and Go (Tug) test		52 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	4 weeks
Secondary	Pain (NRS)	Maximum hip pain during the last week	8 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)		4 weeks
Secondary	Satisfaction with operated hip (NRS)		8 weeks
Secondary	Satisfaction with operated hip (NRS)		12 weeks
Secondary	Satisfaction with operated hip (NRS)		26 weeks
Secondary	Satisfaction with operated hip (NRS)		52 weeks
Secondary	Motion during healing as measured by radiostereometry.	Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Pattern and time of secondary displacement will be compared between the treatment groups during the first year postoperatively.	52 weeks
Secondary	Motion during healing as measured by plain radiographs.,	The rate and degree of secondary displacement during the first year will be compared between the groups.	52 weeks