Hip Fractures Clinical Trial
Official title:
Augmentation of Pertrochanteric Fracture Proximal Femoral Nail Osteosynthesis Using Calcium Sulphate/Hydroxyapatite Combined With Systemic Bisphosphonate - A Pilot Study of the FARE (Fracture Anchorage and Bone REgeneration) Method
The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails. These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality. The main question we aim to answer are whether promoting new bone formation around the implant is possible with a bone graft substitute (CERAMENTâ„¢ Bone Void Filler) and systemic osteoporosis drug (zoledronic acid) combination, which can strengthen the surgical fixation of the fracture. Participants will consist of patients suffering hip fracture and already scheduled for surgical treatment with a nail. One group will undergo conventional surgery. While the other group will also undergo the same surgery, they will receive CERAMENTâ„¢ Bone Void Filler around the implant as a short, extra step during surgery. This will allow the researchers to see whether new bone is formed during a 6-month follow-up.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 90 Years |
Eligibility | Inclusion Criteria: - Being between 65-90 years of age at the time of fracture - Acute, 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 proximal femoral nail - Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification - Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form Exclusion Criteria: - Previous hip or pelvis fracture on the same side - Concurrent corticosteroid treatment - Concurrent medical osteoporosis treatment - Irreversible coagulopathy or bleeding disorder. o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants. - Concurrent dialysis or elevated creatinine - Presence of hypo- or hyper calcaemia - History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy - 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 - Patient without communicative ability to understand the procedure and participate in the study and the follow-up program, did not consent to be included in the study and/or did not sign the consent form |
Country | Name | City | State |
---|---|---|---|
Turkey | Aksaray University Training and Research Hospital | Aksaray |
Lead Sponsor | Collaborator |
---|---|
Aksaray University | Lund University Hospital |
Turkey,
Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312. — View Citation
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
Sezgin EA, Tor AT, Markeviciute V, Sirka A, Tarasevicius S, Raina DB, Liu Y, Isaksson H, Tagil M, Lidgren L. A combined fracture and mortality risk index useful for treatment stratification in hip fragility fractures. Jt Dis Relat Surg. 2021;32(3):583-589 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of bone density around the helical blade of proximal femoral nail | Change of bone density measured by Dual-energy X-ray absorptiometry (DEXA) scan of bilateral proximal femurs will be evaluated. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant. | 1-week and 6 months after the surgery | |
Primary | Bone remodeling around the helical blade of proximal femoral nail | Bone remodeling around the helical blade will be evaluated by computerized tomography (CT) scan of the pelvis using a program for alleviating metal artefacts. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant. | 1-week and 6 months after the surgery | |
Secondary | Harris Hip Score | The Harris Hip Score (HHS) 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-week and 6 months after the surgery | |
Secondary | Screw position and migration by X-ray | X-ray evaluation will quantify helical blade migration on anteroposterior (AP) radiographs by two investigators independently, accounting for femoral rotation and flexion. | 1-week and 6 months after the surgery | |
Secondary | Evaluation of fracture union | Radiographic evaluation will be performed by two investigators independently to decide whether fracture fixation resulted with union or non-union. | 6 months after the surgery | |
Secondary | Any mechanical complications | Any mechanical complications related to the implant will be recorded. | 6 months after the surgery |
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