A Clinical Trial Study of Hip System in Primary Total Hip Arthroplasty in China

NCT02399007 | Completed

• 1 other identifier: DPS-201301
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 8

Brief Summary

A clinical trial of total Hip system used in Primary Total Hip Arthroplasty in China.

Conditions

Rheumatoid Arthritis; Congenital Hip Dysplasia; Avascular Necrosis

Outcome Measures

Primary Outcomes (1)

• Harris Hip Total Score at 12 months postoperatively

  12 months postoperatively

Secondary Outcomes (2)

• One year non-revision rate where revision is defined as removal of any component for any reason with the exception of infection

  12 months postoperatively

• One year non-revision rate where revision is defined as removal of any component secondary to infection

  12 months postoperatively

Other Outcomes (4)

• Harris Hip Total Score success: success is ≥ 80 points.

  12 months postoperatively

• Patient Reported Outcomes

  Preoperation to 12 months postoperatively

• Radiographs: incidence of clinically relevant radiolucent lines, and osteolysis

  Preoperation to 12 months postoperatively

Study Arms (2)

Total Hip System made in China

EXPERIMENTAL

Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured in China

Device: Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)

Total Hip System made outside of China

ACTIVE COMPARATOR

Patient in this arm will be implanted with Primary Total Hip Arthroplasty Devices Manufactured Outside of China

Device: Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)

Interventions

Total Hip System made in China (SUN, CoCr, Duraloc, Marathon) DEVICE

SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)

Total Hip System made in China

Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon) DEVICE

Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)

Total Hip System made outside of China

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is ≥55, and ≤80 years old
• The Subject must be of Chinese ethnic descent and be willing to return on three occasions for clinical evaluations.
• Subject is a suitable candidate for primary total hip replacement using the devices described in this CIP
• Subject must meet all criteria specified in BOTH SUN hip stem and Summit hip stem instructions for use (IFU)
• Before surgery, subject is willing and able to sign the informed consent form approved by the Institutional Review Board (IRB), Ethics Committee (EC) or Ethical Review Board (ERB).
• Subject, in the opinion of the Clinical Investigator, is able to understand this clinical investigation and co-operate with investigational procedures.
• Subject must be comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the patient reported outcomes (PROs) in the CIP.
• Subject is receiving a unilateral hip replacement or, if a contralateral hip replacement is anticipated, the surgery must occur within 6 months of the first study hip. The second hip will not be enrolled in the study.

You may not qualify if:

• Subject does not provide written voluntary consent to participate in the clinical study.
• The Subject is a woman who is pregnant or lactating.
• Subjects who have undergone THA in contralateral hip within the past 6 months.
• Contralateral hip has been enrolled in the study.
• Presence of any previous prosthetic hip replacement device in affected hip.
• Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the affected hip
• Subject has hip dysplasia CROWE classification grade of 3 or 4.
• Above knee amputation of either contralateral or ipsilateral leg
• Subject is anticipated to require a contralateral THA between 6 months and 1-year.
• Subject has an active infection
• Subject has a malignant disease, severe condition, alcohol or drug addiction and/or mental disorders that the investigator believes will interfere with the study participation.
• Subjects with severe osteoporosis, metabolic bone disease, radioactive bone disease or tumor in the bone surrounding the hip joint that, in the opinion of the investigator, will negatively impact implant fixation and the outcome of the investigation;
• Subject has significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, cerebral infarction, hemiplegia, Charcot disease).
• Subject is not comfortable with speaking, reading, and understanding questions and providing responses in an available translated language for the PROs in the CIP.
• Subject has a medical condition with less than 2 years of life expectancy due to other medical conditions.

Sponsors & Collaborators

• Johnson & Johnson Medical (Suzhou) Ltd.: lead

Study Sites (8)

The first affiliated hospital of Guangzhou Tranditional Meidical University

Guangzhou, Guangdong, China

Location

The third affiliated hospital of Hebei University

Shijiazhuang, Hebei, China

Location

The second affiiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The first affiliated hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The affiliated hosoital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

The First Affiliated Hospital of Xinjiang Medicine University

Hohhot, Xinjiang, China

Location

The general hospital of Kunming

Kunming, Yunnan, China

Location

The second Affiliated Hospital of Zhejiang Medicine University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Hip Dislocation, Congenital; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shigui Yan

  The second Affiliated Hospital of Zhejiang Medicine University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 26, 2015
• Study Start: June 7, 2015
• Primary Completion: December 4, 2017
• Study Completion: January 17, 2018
• Last Updated: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)