NCT02347397

Project JAY HAP Registration Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Smith & Nephew Orthopaedics (Beijing) Limited · Industry
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Femoral Neck Fractures

Interventions

Type	Name	Description
DEVICE	SS Bipolar Head + SL-TWIN Stem	Subject will undergo hemiarthroplasty surgery with SS Bipolar Head \& SL-TWIN Stem
DEVICE	Bipolar Head + SL-PLUS Stem	Subject will undergo hemiarthroplasty surgery with Bipolar Head \& SL-PLUS Stem

Timeline

• Start date: 2015-04-29
• Primary completion: 2017-10-16
• Completion: 2017-10-16
• First posted: 2015-01-27
• Last updated: 2018-03-02

Locations

5 sites across 1 country: China