Trochanteric Fracture of Femur Clinical Trial
Official title:
An Open-labelled Pilot Study to Evaluate Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate for Trochanteric Femur Fracture
Verified date | January 2024 |
Source | Lithuanian University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to study the process of bone regeneration around a metal device in the femoral neck canal using a synthetic bone substitute Cerament bone void filler (BVF) and bisphosphonate (Zometa) locally or systemically that affects bone metabolism. Furthermore, fracture healing and implant migration will be investigated.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients 65-90 years of age; - Fame classification with low mortality and high fracture risk. - Unilateral proximal hip fracture ((AO Foundation/Orthopaedic Trauma Association (AO/OTA): A1 and A2)) caused by low energy trauma (physical condition eligible for surgery with dynamic hip screw); - Patient with a communicative ability to understand the procedure and participate in the study and the follow-up program. Exclusion Criteria: - Previous hip or pelvic fractures on the same side, - Concurrent oral treatment with corticosteroids, and/or osteoporosis medication - Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants; - Concurrent dialysis or elevated creatinine - Hypo or hyper calcaemia - Active treatment due to malignancy including ongoing or completed radiotherapy involving the pelvis/hip area, - Fractures involving acetabulum - Active systemic infection or local skin infection at the incision site - Known hyperthyroidism or thyroid adenoma, - History of serious reaction to iodine based radio contrast agents |
Country | Name | City | State |
---|---|---|---|
Lithuania | Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian University of Health Sciences | Lund University Hospital |
Lithuania,
Raina DB, Markeviciute V, Stravinskas M, Kok J, Jacobson I, Liu Y, Sezgin EA, Isaksson H, Zwingenberger S, Tagil M, Tarasevicius S, Lidgren L. A New Augmentation Method for Improved Screw Fixation in Fragile Bone. Front Bioeng Biotechnol. 2022 Mar 2;10:81 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of bone density and remodeling around the head of dynamic screw | Bone density and remodelling around a dynamic hip screw will be investigated by CT scan using a program for alleviating metal artefacts. A 20% increase in bone density is expected to be significant and clinically relevant. | 1.5, 3, 6 months | |
Secondary | Change of Harris Hip Score (HHS) in different group patients | The HHS score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result. | 1.5, 3 and 6 months | |
Secondary | Change of the Screw migration by X-ray | Quantify dynamic hip screw (DHS®) migration on serial anteroposterior (AP) radiographs by accounting for femoral rotation and flexion. | 1.5, 3 and 6 months |
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