Project JAY THA Registration Study

NCT02347384 | Completed

• 1 other identifier: 14-4560-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  1 year post-operative

Secondary Outcomes (1)

• Composite Clinical Success, as indicated by A) No revision of any device component; and B) Total Harris Hip Score greater than or equal to 80 (excellent to good score); and C) Radiologic success.

  1 year post-operative

Other Outcomes (3)

• The Western Ontario and McMaster Universities Arthritis Index(WOMAC)

  1 year post-operative

• SF-12 Health Survey

  1 year post-operative

• Number of adverse events

  Up to 1 year post-operative

Study Arms (2)

Delta PLUS Femoral Head + SL-TWIN Stem

EXPERIMENTAL

Subject will be implanted with Delta PLUS Femoral Head \& SL-TWIN Stem

Device: Delta PLUS Femoral Head + SL-TWIN Stem

BIOLOX forte ball head + SL-PLUS Stem

ACTIVE COMPARATOR

Subject will be implanted with BIOLOX forte ball head \& SL-PLUS Stem

Device: BIOLOX forte ball head + SL-PLUS Stem

Interventions

Delta PLUS Femoral Head + SL-TWIN Stem DEVICE

Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head \& SL-TWIN Stem

Delta PLUS Femoral Head + SL-TWIN Stem

BIOLOX forte ball head + SL-PLUS Stem DEVICE

Subject will undergo total hip arthroplasty with BIOLOX forte ball head \& SL-PLUS Stem

BIOLOX forte ball head + SL-PLUS Stem

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, aged between 50 and 75 years inclusive of Chinese ethnicity.
• Subject presents with osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis of hip joint, developmental dysplasia of the hip, or femoral neck fracture requiring primary total hip replacement.
• Subject who is able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained by signing and dating an EC-approved consent form.
• Subject who is able to understand this clinical study, co-operates with the investigational procedures and is willing to return to the hospital for all the required post-operative follow-ups for up to 12 months.
• Life expectancy of subject is over 2 years.

You may not qualify if:

• Bilateral hip disease with the anticipated need for bilateral hip implant during study participation (i.e., within the next 12 months).
• Subject experienced prior joint replacement surgery on any major joint (hip, knee) in lower limb within the last 12 months.
• Subject with developmental dysplasia of the hip of CROWE grade 3 or 4.
• Subject has known or suspected metal sensitivity.
• Subject is known to have insufficient bone stock resulting from conditions such as cancer, significant osteoporosis or metabolic bone disorders, which cannot provide adequate support and/or fixation to the prosthesis.
• Subject is severely obese (BMI\>35).
• Subject had an active infection or sepsis (treated or untreated).
• Subject has conditions that may compromise implant stability or postoperative recovery (i.e., Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency, hip abduction muscle strength less than grade IV or complete loss, or neuromuscular disease).
• Subject has an emotional or neurological condition that would affect their ability or willingness to participate in the study (e.g. cognitive disorder, mental illness, mental retardation).
• Subject is immunosuppressed, has an autoimmune disorder, or an immunosuppressive disorder. For examples, subject is on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses) or has acquired immunodeficiency syndrome (AIDS).
• Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
• Subject was enrolled in another investigational drug, biologic, or device study in the last 12 months.
• Subject is a woman who is pregnant or lactating，or intends to become pregnant during the course of the study.
• Known alcohol and/or drug abuse

Sponsors & Collaborators

• Smith & Nephew Orthopaedics (Beijing) Limited: lead

Study Sites (4)

Luoyang Orthopedic-Traumatological Hospital

Luoyang, Henan, 471002, China

Location

Inner Mongolia Bao Gang Hospital

Baotou, Inner Mongolia, 014010, China

Location

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830099, China

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis; Developmental Dysplasia of the Hip; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Dislocation; Joint Dislocations; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Li Cao

  First Affiliated Hospital of Xinjiang Medical University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 27, 2015
• Study Start: April 20, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)