Hip FracturesNCT04031209
G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
An observational study of Hip Fractures, run by Zimmer Biomet at 7 sites in South Korea.
Trial summary
This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- G7 Acetabular System
- Type of treatment
- Medical device
- How many people
- 275 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 1 Jan 2020to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.
Who may be able to join
- 55 to 80 years of age, inclusive
- Skeletally mature
- Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
- Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
- Has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved informed consent
Who cannot join
- Is septic, has an active infection or has osteomyelitis at the affected joint
- Has significant osteoporosis as defined by treating surgeon
- Has metabolic disorder(s) which may impair bone formation
- Has osteomalacia
- Has distant foci of infections which may spread to the implant site
- Has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs
Show all 11Show fewer
- Has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery
- Has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Is known to be pregnant
- Is a prisoner, known alcohol or drug abuser or mentally incompetent or unable to understand what participation in this study entails
- Has a known sensitively or allergy to one or more of
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Seoul National University Hospital
Seoul, 03080
Hanyang University Medical Center
Seoul, 04763
Asan medical Centre
Seoul, 05505
Seoul National University Bundang Hospital
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul St. Mary's Hospital
Seoul, 06591
KyungHee University Medical Center
Seoul, 130-872
About this study
Official title: Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
This is a retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
Read the detailed description
The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting
- Conditions
- Hip Fractures
- Being tested
- G7 Acetabular System
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G7 Acetabular SystemDevice
All patients will receive G7 Acetabular System
| Study group | Role | What they receive |
|---|---|---|
| G7 G7 Acetabular System | All patients will receive G7 G7 Acetabular System Receives: Device: G7 Acetabular System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant dislocation rate
Dislocation is defined as the complete loss of articulation contact between two artificial joint components.
Measured: One year post-surgery
Secondary outcomes (6)
Pain and Functional Performance by Oxford Hip Score
The Oxford Hip score consist of 12 disease-specific questions measuring patient-reported pain and function of the hip joint. Responses to each question are formatted as a 5-point Likert scale, scored from 0 (the worst outcome/most symptoms) to 4 (the best outcome / least symptoms). The scores for each question are added together for a final result between 0 and 48.
Measured: Up to 5 years post-surgery
Implant survivorship by revision rates
Cumulative survival rates using a Kaplan-Meier analysis.
Measured: Up to 5 years post-surgery
Quality of life by EQ-5D-5L questionnaire
This 5-level EQ-5D version (EQ-5D-5L) consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The health states may be converted into a single index value where 1 represents full health and 0 represents death. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: Up to 5 years post-surgery
Quality of life by JHEQ
The Japanese Orthopaedic Association hip disease evaluation questionnaire (JHEQ) is a self-administered questionnaire that evaluates the quality of life in patients with hip disease. The questionnaire consists of three subscales: pain (28 points), movement (28 points), and mental (28 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.
Measured: Up to 5 years post-surgery
Pain and Functional Performance by JOA Hip Score
The Japanese Orthopaedic Association (JOA) hip score consists of four subcategories: pain (Pain, 40 points), range of motion (ROM, 20 points), ability to walk (Gait, 20 points), and activities of daily life (ADL, 20 points), with higher scores indicating a better outcome. This measurement is applicable to Japanese population only.
Measured: Up to 5 years post-surgery
Adverse events reported
Summary of adverse events by category, incidence and frequency
Measured: Up to 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Jan 2020
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kee-Hyung Rhyu, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031209
- Sponsor's protocol ID
- CSA2019-02H
- Status last verified
- Dec 2024
- First submitted
- 4 Jul 2019
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective Multi-Center Outcomes Study of G7 Dual Mobility System Used in Total Hip Arthroplasty for the Treatment of Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT04031209
- Acronym / sponsor ID
- CSA2019-02H
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 2019 (actual)
- 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 retrospective and prospective, multi-center, non-comparative, post market clinical follow-up study involving orthopedic surgeons skilled in THA and experienced implanting the devices included in this study.
Detailed description
The objectives of the study are to document the performance and safety of the G7 Dual Mobility System when used in primary total hip arthroplasty for the treatment of femoral neck fracture by analysis of standard scoring systems, radiographs, revision and adverse event records.The study will include a maximum of 15 centers and up to 300 implanted hips. Each center may enroll up to a maximum of 40 hips to permit the consistency of outcomes across a variety of investigators and clinical setting
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G7 G7 Acetabular System | – | Device: G7 Acetabular SystemAll patients will receive G7 G7 Acetabular System |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients who required primary THA for treatment of femoral neck fracture and satisfy eligibility criteria outlined in this section. In order to avoid potential selection bias, each investigator will offer study participation to each consecutive eligible patient presenting as a candidate for primary THA using G7 Dual Mobility System.
Key inclusion criteria (6 listed)
- 55 to 80 years of age, inclusive
- Skeletally mature
- Have undergo treatment or in need of primary THA treatment of non-union, femoral neck fracture, unmanageable by other techniques
- Have G7 Dual Mobility system implanted or decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
- Willing and able to complete scheduled follow-up evaluations as described in the study protocol
Key exclusion criteria (11 listed)
- Is septic, has an active infection or has osteomyelitis at the affected joint
- Has significant osteoporosis as defined by treating surgeon
- Has metabolic disorder(s) which may impair bone formation
- Has osteomalacia
- Has distant foci of infections which may spread to the implant site
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 |
|---|---|---|
| G7 Acetabular SystemAll patients will receive G7 Acetabular System | Device | G7 G7 Acetabular System |
Primary outcome
Implant dislocation rate
Time frame: One year post-surgery
Dislocation is defined as the complete loss of articulation contact between two artificial joint components.
6 secondary outcomes
Pain and Functional Performance by Oxford Hip Score
Time frame: Up to 5 years post-surgery
Implant survivorship by revision rates
Time frame: Up to 5 years post-surgery
Quality of life by EQ-5D-5L questionnaire
Time frame: Up to 5 years post-surgery
Quality of life by JHEQ
Time frame: Up to 5 years post-surgery
Pain and Functional Performance by JOA Hip Score
Time frame: Up to 5 years post-surgery
Adverse events reported
Time frame: Up to 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- 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.
Kee-Hyung Rhyu principal investigator
Kyunghee University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by Zimmer Biomet at 7 sites in South Korea.
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 11 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Implant dislocation rate (time frame: One year post-surgery). 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 18 Dec 2024.