NCT02347384

Project JAY THA Registration Study

A Prospective, Randomized, Multicenter Clinical Study in Chinese Subjects to Compare the Safety and Efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem With BIOLOX Forte Ball Head and SL-PLUS Stem in Total Hip Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Smith & Nephew Orthopaedics (Beijing) Limited · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multicenter clinical study in Chinese subjects to compare the safety and efficacy of the Delta PLUS Femoral Head and SL-TWIN Stem with BIOLOX forte ball head and SL-PLUS Stem in total hip arthroplasty

Detailed description

As the incidence of joint disease continues to increase, an ever growing percentage of the affected population will undergo total hip arthroplasty (THA). This recent upward trend for THA procedures appears to be directly related to the prevalence of certain health factors. Specifically, longer life spans, rising obesity rates, and increasing physical activity levels in relatively younger populations are all examples of factors that may significantly contribute to hip degeneration. While strategies such as weight reduction, lifestyle change, or drug therapy may offer temporary relief from the symptoms of joint degeneration, THA remains the standard of care for subjects experiencing significant losses in quality of life due to advanced hip disease. 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 Delta PLUS Femoral Head + SL-TWIN Stem compared to a randomized concurrent control group of subjects implanted with the BIOLOX forte ball head + SL-PLUS Stem in terms of mean Harris Hip Score (HHS) at 1 year.

Conditions

• Osteoarthritis
• Rheumatoid Arthritis
• Post-traumatic Arthritis
• Avascular Necrosis
• Developmental Dysplasia of the Hip
• Femoral Neck Fracture

Interventions

Type	Name	Description
DEVICE	Delta PLUS Femoral Head + SL-TWIN Stem	Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head \& SL-TWIN Stem
DEVICE	BIOLOX forte ball head + SL-PLUS Stem	Subject will undergo total hip arthroplasty with BIOLOX forte ball head \& SL-PLUS Stem

Timeline

• Start date: 2015-04-20
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-01-27
• Last updated: 2017-11-14

Locations

4 sites across 1 country: China