Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure (Densiprobe)

AO Clinical Investigation and Publishing Documentation

Status

Terminated

Conditions

Osteoporosis

Hip Fractures

Femoral Fractures

Bone Density

Treatments

Device: DensiProbe Hip

Study type

Interventional

Funder types

Other

Identifiers

NCT00822159

Densiprobe-08

Details and patient eligibility

About

Hip fractures mostly occur in elderly people with low bone strength. Bone strength is determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to measure BMD. However, BMD just provides information regarding the quantity of mineral in bone, which is only one component of bone strength. To date there is no reliable method to assess bone strength in vivo. Therefore, a method to assess bone strength beyond BMD would provide additional information regarding the patients' risk of bone related fixation failure after fracture fixation.

DensiProbe is a new diagnostic device that was developed for intra-operative assessment of mechanical stability of the bone in the proximal femur. It consists of a drill bit like tool and an electronic system to measure the peak torque to break-away of trabecular bone in the femoral head of patients undergoing DHS surgical treatment. In a cadaver study comparing bone mineral density measured by quantitative computed tomography with bone strength measured by DensiProbe a high correlation between these two parameters could be shown. In a clinical pilot study a significant correlation between DensiProbe measurements and BMD measured by DXA at the femoral neck in patients with hip fractures could be shown. However, no perfect correlation was expected because DensiProbe measures bone strength, which is only partly caused by BMD.

Bone related fixation failure, such as secondary loss of reduction, is influenced by bone strength, bone mineral density, fracture type, fracture reduction and primary positioning of the implant. The predictive value of DensiProbe measurements for secondary loss of reduction needs to be investigated. If DensiProbe turned out to be an effective screening tool for patients with low bone strength that are on higher risk of the aforementioned complications these patients may in future benefit from alternative treatment methods (e.g. augmentation techniques) in order to reduce bone related fixation failure.

The primary aim of the present study is to investigate if bone strength measured by DensiProbeTM Hip (DensiProbe) is an independent factor to predict secondary loss of reduction (screw migration of 5 mm or more and / or telescoping of 10 mm or more) in patients with hip fractures after fracture fixation with DHS.

Enrollment

198 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients 50 years or older
Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
Patients willing to participate in the study according to the clinical investigation plan
Patients able to understand and read country national language at an elementary level
Signed written informed consent by the patient or legal guardian

Exclusion criteria

Bilateral hip fractures (at present or in the past)
Open hip fracture
Any previous surgical procedures of the hip (ipsilateral / contralateral)
More than 7 days between injury and surgery
Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
Patients being pregnant or breast-feeding
Pathologic fractures
Active malignancy
Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
Drug or alcohol abuse
Patients having participated in any other device or drug related clinical trial within the previous month