This is a prospective, randomized, multicenter clinical study in elderly Chinese subjects to compare the safety and efficacy of the SS Bipolar Head and SL-TWIN Stem with Bipolar Head and SL-PLUS Stem in hemiarthroplasty of the hip
Elderly patients, especially post-menopausal women, often suffer a femoral neck fracture due to osteoporosis, even with very little trauma. Femoral neck fracture is a common disease in elderly patients, it accounts for 3.6% of total body fractures. In China, as the population continues to age and life expectancy increases, the incidence of femoral neck fracture has significantly increased. Hip replacement surgery includes total hip arthroplasty (THA) and hemiarthroplasty (HAP). Hemiarthroplasty of the hip involves replacement of the diseased, affected, or broken femoral head and/or neck with a prosthetic component. Hemiarthroplasty does not involve resurfacing of the acetabulum, and therefore a bipolar or unipolar prosthetic head articulates against the host acetabular articular cartilage. Avoiding the need, when appropriate, to resurface the acetabulum helps to minimize surgical trauma, operative time and dislocation risk, while preserving acetabular bone stock. These also result in shorter bed stay and faster recovery comparing with the THA. There has been an increase in imported hip prostheses during the past decade, so that surgeons now have more choices of implants. However, the high cost of imported prostheses has become a barrier to the development of hip replacement in China and caused many patients requiring immediate hip replacement to have to delay or miss their surgery. The development and promotion of high-quality domestic joint implants and surgical instruments is the key to the development of joint replacement technique in China. The primary objective of this study is to demonstrate non-inferiority of subjects implanted with the SS Bipolar Head + SL-TWIN Stem compared to a randomized concurrent control group of subjects implanted with the Bipolar Head + SL-PLUS Stem in terms of mean Harris Hip Score (HHS) at 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
Subject will undergo hemiarthroplasty surgery with SS Bipolar Head \& SL-TWIN Stem
Subject will undergo hemiarthroplasty surgery with Bipolar Head \& SL-PLUS Stem
Haikou People's Hospital
Haikou, Hainan, China
Luoyang Orthopedic-Traumatological Hospital
Luoyang, Henan, China
Inner Mongolia Bao Gang Hospital
Baotou, Inner Mongolia, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Harris Hip Score
Time frame: 1 year post-operative
Composite Clinical Success, as indicated by A) No revision of any device component; and B) Total Harris Hip Score greater than or equal to 80 (excellent to good score); and C) Radiologic success.
A successful individual outcome for a subject in hemiarthroplasty will be characterized at 1 year postoperative by a composite of three success criteria: A. No revision of any device component; and B. Total Harris Hip Score greater than or equal to 80 (excellent to good score); and C. Radiologic success.
Time frame: 1 year post-operative
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Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China