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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02294747
Enrollment
31
Registered
2014-11-19
Start date
2014-11-30
Completion date
2018-12-31
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures, Intertrochanteric Fractures, Trochanteric Fractures

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.

Interventions

DEVICESliding Hip Screw with Trochanteric Stabilization Plate
DEVICESliding Hip Screw without Trochanteric Stabilization Plate

Sponsors

Diakonhjemmet Hospital
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fracture displacement during healing measured with radiostereometry52 weeksWill 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.

Secondary

MeasureTime frameDescription
Perioperative blood loss1 week
Time of surgery1 week
Eq5d52 weeksHealth Related Quality of Life (Hrqol).
Time to union as measured by RSA (cessation of motion) and radiographsWill be examined at 4, 8, 12, 26 and 52 weeksWhen RSA shows that no motion has happened between two time points the fracture will be regarded as healed at the former time point.
Time to union as measured by plain radiographs and clinical findingsWill be examined at 4, 8, 12, 26 and 52 weeksComposite 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.
Harris Hip Score52 weeksWill be examined at 4, 8, 12, 26 and 52 weeks
Motion during healing as measured by radiostereometry.52 weeksWill 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.
Motion during healing as measured by plain radiographs.,52 weeksThe rate and degree of secondary displacement during the first year will be compared between the groups.
Postoperative pain (NRS) while in hospital1 weekPain at mobilization (NRS) at discharge
Timed Up and Go (Tug) test4 weeks
Pain (NRS)4 weeksMaximum hip pain during the last week
Satisfaction with operated hip (NRS)4 weeks

Other

MeasureTime frameDescription
Reoperation for healing problems52 weeksAny additional surgery addressing healing problems or hardware failure
Mortality52 weeksAny reason

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026