Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-04-20
2016-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Delta PLUS Femoral Head + SL-TWIN Stem
Subject will be implanted with Delta PLUS Femoral Head \& SL-TWIN Stem
Delta PLUS Femoral Head + SL-TWIN Stem
Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head \& SL-TWIN Stem
BIOLOX forte ball head + SL-PLUS Stem
Subject will be implanted with BIOLOX forte ball head \& SL-PLUS Stem
BIOLOX forte ball head + SL-PLUS Stem
Subject will undergo total hip arthroplasty with BIOLOX forte ball head \& SL-PLUS Stem
Interventions
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Delta PLUS Femoral Head + SL-TWIN Stem
Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head \& SL-TWIN Stem
BIOLOX forte ball head + SL-PLUS Stem
Subject will undergo total hip arthroplasty with BIOLOX forte ball head \& SL-PLUS Stem
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
50 Years
75 Years
ALL
No
Sponsors
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Smith & Nephew Orthopaedics (Beijing) Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Li Cao
Role: STUDY_CHAIR
First Affiliated Hospital of Xinjiang Medical University
Locations
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Luoyang Orthopedic-Traumatological Hospital
Luoyang, Henan, China
Inner Mongolia Bao Gang Hospital
Baotou, Inner Mongolia, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
Countries
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Other Identifiers
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14-4560-02
Identifier Type: -
Identifier Source: org_study_id