Project JAY THA Registration Study

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02347384
Study type	Interventional
Source	Smith & Nephew Orthopaedics (Beijing) Limited
Contact
Status	Completed
Phase	N/A
Start date	April 20, 2015
Completion date	November 1, 2016

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.