Project JAY HAP Registration Study
Primary Purpose
Femoral Neck Fractures
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SS Bipolar Head + SL-TWIN Stem
Bipolar Head + SL-PLUS Stem
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects, aged between 65 and 90 years inclusive of Chinese ethnicity.
- Subject presents with femoral neck fracture (Garden Type II, III, or IV) requiring hemiarthroplasty of the hip.
- Subject is able to move independently before the fracture, with or without the use of walking aids .
- 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:
- 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 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 is not suitable for hemiarthroplasty (i.e., inflammatory arthritis, pathological fractures, etc.)
- 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.
- Known alcohol and/or drug abuse
Sites / Locations
- Haikou People's Hospital
- Luoyang Orthopedic-Traumatological Hospital
- Inner Mongolia Bao Gang Hospital
- The First Teaching Hospital of Xinjiang Medical University
- Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SS Bipolar Head + SL-TWIN Stem
Bipolar Head + SL-PLUS Stem
Arm Description
Subject will be implanted with the SS Bipolar Head & SL-TWIN Stem
Subject will be implanted with the Bipolar Head & SL-PLUS Stem
Outcomes
Primary Outcome Measures
Harris Hip Score
Secondary Outcome Measures
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.
A successful individual outcome for a subject in hemiarthroplasty will be characterized at 1 year postoperative by a composite of three success criteria:
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.
Full Information
NCT ID
NCT02347397
First Posted
January 9, 2015
Last Updated
March 1, 2018
Sponsor
Smith & Nephew Orthopaedics (Beijing) Limited
1. Study Identification
Unique Protocol Identification Number
NCT02347397
Brief Title
Project JAY HAP Registration Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 29, 2015 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew Orthopaedics (Beijing) Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SS Bipolar Head + SL-TWIN Stem
Arm Type
Experimental
Arm Description
Subject will be implanted with the SS Bipolar Head & SL-TWIN Stem
Arm Title
Bipolar Head + SL-PLUS Stem
Arm Type
Active Comparator
Arm Description
Subject will be implanted with the Bipolar Head & SL-PLUS Stem
Intervention Type
Device
Intervention Name(s)
SS Bipolar Head + SL-TWIN Stem
Intervention Description
Subject will undergo hemiarthroplasty surgery with SS Bipolar Head & SL-TWIN Stem
Intervention Type
Device
Intervention Name(s)
Bipolar Head + SL-PLUS Stem
Intervention Description
Subject will undergo hemiarthroplasty surgery with Bipolar Head & SL-PLUS Stem
Primary Outcome Measure Information:
Title
Harris Hip Score
Time Frame
1 year post-operative
Secondary Outcome Measure Information:
Title
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.
Description
A successful individual outcome for a subject in hemiarthroplasty will be characterized at 1 year postoperative by a composite of three success criteria:
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.
Time Frame
1 year post-operative
Other Pre-specified Outcome Measures:
Title
Barthel Index
Time Frame
1 year post-operative
Title
SF-12 Health Survey
Time Frame
1 year post-operative
Title
Number of adverse events
Time Frame
Up to 1 year post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, aged between 65 and 90 years inclusive of Chinese ethnicity.
Subject presents with femoral neck fracture (Garden Type II, III, or IV) requiring hemiarthroplasty of the hip.
Subject is able to move independently before the fracture, with or without the use of walking aids .
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:
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 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 is not suitable for hemiarthroplasty (i.e., inflammatory arthritis, pathological fractures, etc.)
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.
Known alcohol and/or drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Cao
Organizational Affiliation
First Affiliated Hospital of Xinjiang Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haikou People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570208
Country
China
Facility Name
Luoyang Orthopedic-Traumatological Hospital
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471002
Country
China
Facility Name
Inner Mongolia Bao Gang Hospital
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China
Facility Name
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
City
Ürümqi
State/Province
Xinjiang
ZIP/Postal Code
830099
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Project JAY HAP Registration Study
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