| STUDY PROTOCOL |
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| Year : 2016 | Volume
: 1
| Issue : 3 | Page : 127-133 |
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Feasibility of implantation of a cemented femoral stem in the treatment of osteoporotic femoral neck fracture in elderly patients: study protocol of a randomized controlled trial
Rong Ren, Ling-wei Li, Qi-fa Guo
Qinghai University Affiliated Hospital, Xining, Qinghai Province, China
Correspondence Address:
Rong Ren
Qinghai University Affiliated Hospital, Xining, Qinghai Province
China
 Source of Support: This work was supported by Science and Technology Fund of Qinghai Province of China, Conflict of Interest: None  | Check |
DOI: 10.4103/2468-5658.191355
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Background: Osteogenesis is a common problem after surgery for femoral neck fracture in elderly patients. Internal fixation for the treatment of femoral neck fracture should be performed to optimize bone remodeling and strengthen fractured bone trabeculae, with the aim of achieving strong fixation from the perspective of biomechanics. Percutaneous internal fixation with cannulated compression screws has become a preferred treatment method of osteoporotic femoral neck fracture in elderly patients, but the insufficient holding power of the screws used in the femoral neck does not lead to strong fixation. An alternative, joint prosthesis is recommended for the repair of femoral neck fracture in elderly patients. However, its long-term therapeutic effects in the treatment of osteoporotic fracture of proximal femoral neck remain poorly understood in patients with avascular necrosis of the femoral head.
Methods/Design: A single-center, prospective, randomized controlled, open-label trial will be performed in Qinghai University Affiliated Hospital, Qinghai, China. One hundred patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to two groups. Group 1 will undergo percutaneous internal fixation with cannulated compression screws (n = 50) and group 2 will be implanted with cemented femoral stem (n = 50). The primary outcome measure is hip joint function evaluated by Harris hip scores taken at baseline (prior to surgery), 1, 6 and 12 months after surgery. The secondary outcome measure is hip joint pain score on a Visual Analogue Scale at baseline (prior to surgery), 1, 6 and 12 months after surgery. Other outcome measures include the percentage of patients presenting with femoral head collapse, bone non-union, sterile prosthesis loosening or peri-prosthesis infection 6 and 12 months after surgery. These will be used to evaluate the histocompatibility of biomaterial with the host tissue.
Discussion: Randomized controlled studies are scarce on the long-term therapeutic effects of surgery in the treatment of osteoporotic femoral neck fracture in elderly patients presenting with avascular necrosis of the femoral head. This will be the first study to investigate the feasibility of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture complicated by avascular necrosis of the femoral head. It will test from the perspectives of safety and efficacy through a stringent randomized controlled trial based on a 12-month follow-up evaluation.
Trial registration: ClinicalTrial.gov identifier: NCT02901938; registered on 12 September 2016.
Ethics: This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China (approval number: QHY1019W) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.
Informed consent: Signed informed consent regarding trial procedure and treatment will be obtained from each patient or their guardians. |
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