Femoral Neck FracturesNCT02347397
Project JAY HAP Registration Study
A study testing SS Bipolar Head + SL-TWIN Stem and Bipolar Head + SL-PLUS Stem in people with Femoral Neck Fractures, run by Smith & Nephew Orthopaedics (Beijing) Limited at 5 sites in China.
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 Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Femoral Neck Fractures
- What is being tested?
- SS Bipolar Head + SL-TWIN Stem and Bipolar Head + SL-PLUS Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesChina
- Study dates
- 29 Apr 2015to 16 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Show all 13Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Inner Mongolia Bao Gang Hospital
Baotou, Inner Mongolia, 014010
Haikou People's Hospital
Haikou, Hainan, 570208
Luoyang Orthopedic-Traumatological Hospital
Luoyang, Henan, 471002
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830099
About this 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
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
Read the 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.
- Conditions
- Femoral Neck Fractures
- Being tested
- SS Bipolar Head + SL-TWIN Stem, Bipolar Head + SL-PLUS Stem
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS Bipolar Head + SL-TWIN StemDevice
Subject will undergo hemiarthroplasty surgery with SS Bipolar Head \& SL-TWIN Stem
Bipolar Head + SL-PLUS StemDevice
Subject will undergo hemiarthroplasty surgery with Bipolar Head \& SL-PLUS Stem
| Study group | Role | What they receive |
|---|---|---|
| SS Bipolar Head + SL-TWIN Stem | Experimental | Subject will be implanted with the SS Bipolar Head \& SL-TWIN Stem Receives: Device: SS Bipolar Head + SL-TWIN Stem |
| Bipolar Head + SL-PLUS Stem | Active comparator | Subject will be implanted with the Bipolar Head \& SL-PLUS Stem Receives: Device: Bipolar Head + SL-PLUS Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Measured: 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.
A successful individual outcome for a subject in hemiarthroplasty will be characterized at 1 year postoperative by a composite of three success criteria:
- 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.
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study start29 Apr 2015
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Orthopaedics (Beijing) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Cao, Principal investigator, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347397
- Sponsor's protocol ID
- 14-4561-01
- Status last verified
- Mar 2018
- First submitted
- 9 Jan 2015
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02347397
- Acronym / sponsor ID
- 14-4561-01
- Conditions
- Femoral Neck Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Smith & Nephew Orthopaedics (Beijing) LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SS Bipolar Head + SL-TWIN Stem | Experimental | Device: SS Bipolar Head + SL-TWIN StemSubject will be implanted with the SS Bipolar Head \& SL-TWIN Stem |
| Bipolar Head + SL-PLUS Stem | Active comparator | Device: Bipolar Head + SL-PLUS StemSubject will be implanted with the Bipolar Head \& SL-PLUS Stem |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS Bipolar Head + SL-TWIN StemSubject will undergo hemiarthroplasty surgery with SS Bipolar Head \& SL-TWIN Stem | Device | SS Bipolar Head + SL-TWIN Stem |
| Bipolar Head + SL-PLUS StemSubject will undergo hemiarthroplasty surgery with Bipolar Head \& SL-PLUS Stem | Device | Bipolar Head + SL-PLUS Stem |
Primary outcome
Harris Hip Score
Time frame: 1 year post-operative
1 secondary outcome
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.
Time frame: 1 year post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Cao principal investigator
First Affiliated Hospital of Xinjiang Medical University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SS Bipolar Head + SL-TWIN Stem and Bipolar Head + SL-PLUS Stem in people with Femoral Neck Fractures, run by Smith & Nephew Orthopaedics (Beijing) Limited at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris Hip Score (time frame: 1 year post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.