Project JAY HAP Registration Study

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Femoral Neck Fractures

Clinical Trial Details

NCT number	NCT02347397
Study type	Interventional
Source	Smith & Nephew Orthopaedics (Beijing) Limited
Contact
Status	Completed
Phase	N/A
Start date	April 29, 2015
Completion date	October 16, 2017

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04462172` - A Prospective Multicenter Cohort Study About Internal Fixation Using FNS Versus MCS for Femoral Neck Fracture	N/A
Enrolling by invitation	`NCT04110639` - Intraoperative Monitoring of Femoral Head Perfusion	N/A
Terminated	`NCT01908751` - Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)	Phase 3
Recruiting	`NCT01934049` - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty	Phase 4
Recruiting	`NCT01219088` - Intrathecal Morphine,Femoral Nerve Block,Periarticular Bupivacaine Infiltration for Pain After Intramedullary Hip Screw	Phase 4
Not yet recruiting	`NCT00749710` - Blood Loss and Complications of Internal Fixation of Femoral Neck Fractures in Patients Treated With Clopidogrel	N/A
Active, not recruiting	`NCT00491673` - A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures	N/A
Completed	`NCT00464230` - Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures	Phase 4
Recruiting	`NCT03966716` - Hips Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients (HipSTHeR)	N/A
Recruiting	`NCT05227924` - Safety and Performance Assessment of the SYMBOL Range of Medical Devices in Patients Underlying Total Hip Arthroplasty
Completed	`NCT03666637` - Femoral Neck Fracture in Adult and Avascular Necrosis and Nonunion
Terminated	`NCT03721835` - Safety Study of Femoral Neck Fracture System	N/A
Not yet recruiting	`NCT04408053` - Mini-invasive Preventive Fixation of the Contralateral Femoral Neck in Patients Operated on for a Femoral Neck Fracture	Phase 3
Recruiting	`NCT04577261` - FNS (FEMORAL NECK SYSTEM) Study
Recruiting	`NCT04589598` - Femoral Neck System and Multiple Cannulated Screws in Femoral Neck Fracture	N/A
Not yet recruiting	`NCT06078371` - Opioid-Free Pain Treatment in Trauma Patients	N/A
Withdrawn	`NCT02198820` - Practice Survey on Femoral Neck Fractures and the Incidence of Type of Anesthesia on Patient Outcome	N/A
Active, not recruiting	`NCT02246335` - Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly	N/A
Not yet recruiting	`NCT00926666` - A Dose Finding Study for Pain Relief of a Broken Hip	Phase 4

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.