Trochanteric Fracture of FemurNCT03196193
CM Asia Nail With AS2 Without AS2 （AS2 Study）
A study testing Open Reduction and Internal Fixation, ZNN CM Asia and Anterior Support Screw in people with Trochanteric Fracture of Femur, run by Zimmer Biomet at 12 sites in Japan.
Trial summary
The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Trochanteric Fracture of Femur
- What is being tested?
- Open Reduction and Internal Fixation, ZNN CM Asia and Anterior Support Screw
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 12 sitesJapan
- Study dates
- 21 Mar 2017to 9 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria.
- Eligible for intramedullary nailing.
- Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))
- Japanese Male or female
- > 20 years of age
- Primary closed intertrochanteric fracture of the femur
- Subjects willing to return for follow-up evaluations.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study.
- Patient who cannot take CT image within 3 days and 2-3weeks after surgery.
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Japan12 sites
Kasugai Municipal Hospital
Aichi, Kasugai, 486-8510
Kyushu Central Hospital
Fukuoka, 815-8588
Hoshigaoka Medical Center
Hirakata, Osaka, 573-8511
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kure Kyosai Hospital
Kure, Hiroshima, 737-8505
Niigata Central Hospital
Niigata, 950-8556
Numazu City Hospital
Numazu, Shizuoka, 410-0302
Okayama Red Cross Hospital
Okayama, 700-8607
Okayama Rosai Hospital
Okayama, 702-8055
Saga Pref. Medical Centre Koseikan
Saga, 840-8571
Saiseikai Takaoka Hospital
Takaoka, Toyama, 933-8525
Toyooka Hospital
Toyooka, Hyōgo, 668-8501
About this study
Official title: Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.
Read the detailed description
Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).
Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information
- Conditions
- Trochanteric Fracture of Femur
- Being tested
- Open Reduction and Internal Fixation, ZNN CM Asia, Anterior Support Screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Reduction and Internal FixationProcedure or surgery
Fractured bone fragments are reduced and stabilized by intramedullary nail.
ZNN CM AsiaDevice
Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
Anterior Support ScrewDevice
Also called ACE 4.5/5.0mm cannulated lag-screw
Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.
| Study group | Role | What they receive |
|---|---|---|
| ZNN CM Asia with AS2 technique | Experimental | Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail.
Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw). Receives: Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia; Device: Anterior Support Screw |
| ZNN CM Asia without AS2 technique | Active comparator | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Receives: Procedure: Open Reduction and Internal Fixation; Device: ZNN CM Asia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patient With and Without Excessive Lag Screw Sliding Distance
Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.
Measured: Postoperative 2-3 week
Secondary outcomes (3)
Surgery Time
Surgery time from skin incision to closure
Measured: Intraoperative, an average of 1 hour
Image Assessment Using Computed Tomography (CT)
Number of patient was counted based on CT measurement results. When the fracture reduction position achieved at surgery was maintained at 2 to 3 weeks, then the patient was categorized as success (Reduction position maintained). On the other hand, patient was categorized as failure (Reduction position changed) in the case that the fracture reduction position was changed.
Fracture repair position was categorized into three; "Anterior", "Neutral" or "Posterior" based on relative position of proximal bone fragment and distal bone fragment.
This analysis only includes patients whose fracture reduction position at immediate postoperative CT was either "Anterior" or "Neutral".
If both immediate and 2-3 weeks postoperative CT images show same fracture reduction position (example: "Anterior" at immediate postoperatively \& "Anterior" at 2-3 weeks postoperatively), then the patient was recognized as Success (Reduction position maintained).
Measured: 2-3 weeks postoperatively
Intraoperative Safety
This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start21 Mar 2017
- Primary completion2 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Trochanteric Fracture of FemurStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takashi Maehara, MD, Ph. D, Principal investigator, Kagawa Rosai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196193
- Sponsor's protocol ID
- T.CR.I.AP.16.4
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2017
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing Zimmer Natural Nail System Cephalomedullary Asia Nail With Anterior Support Screw (AS2) Versus Conventional Technique
- ClinicalTrials.gov ID
- NCT03196193
- Acronym / sponsor ID
- T.CR.I.AP.16.4
- Conditions
- Trochanteric Fracture of Femur
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare reduction positon maintenance rate at 3 weeks post-operatively between patients operated with Anterior Support Screw (AS2) and without AS2 technique in RCT setting. Total 240 cases(each arm 120 cases) will be enrolled at maximum 15sites, total study duration is 22months.
Detailed description
Objective： To compare fracture reduction maintenance rate at 2-3weeks post-operatively between patients operated with AS2 (investigational group) and patients operated without AS2 (Control group) using same implant system (ZNN CM Asia, Zimmer Biomet).
Endpoint： Primary： The rate of reduction position maintenance at 2-3 weeks post-operatively. Secondary： Surgery time / fracture type / postoperative reduction position / CT assessment / Safety information
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.
| Arm | Type | Receives |
|---|---|---|
| ZNN CM Asia with AS2 technique | Experimental | Procedure: Open Reduction and Internal Fixation, Device: ZNN CM Asia, Device: Anterior Support ScrewOpen Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail. Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw). |
| ZNN CM Asia without AS2 technique | Active comparator | Procedure: Open Reduction and Internal Fixation, Device: ZNN CM AsiaTrochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria.
- Eligible for intramedullary nailing.
- Fracture type is classified as 3-partB or 4-part fracture in 3D-CT (Three Dimensional Computed Tomography) classification (Nakano), and combination with a subtype P in lateral classification (Ikuta) at preoperative CT (Computed Tomography) assessment.(In the case of classified in radiograph (X-ray) at preoperative: Classified as Type 4 or Type 5 in Jensen classification, and combination of subtype P in lateral classification (Ikuta))
- Japanese Male or female
- > 20 years of age
Key exclusion criteria (3 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study.
- Patient who cannot take CT image within 3 days and 2-3weeks after surgery.
- Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
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 |
|---|---|---|
| Open Reduction and Internal FixationFractured bone fragments are reduced and stabilized by intramedullary nail. | Procedure or surgery | ZNN CM Asia with AS2 technique, ZNN CM Asia without AS2 technique |
| ZNN CM AsiaReduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. | Device | ZNN CM Asia with AS2 technique, ZNN CM Asia without AS2 technique |
| Anterior Support ScrewAlso: ACE 4.5/5.0mm cannulated lag-screwExperimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. | Device | ZNN CM Asia with AS2 technique |
Primary outcome
Number of Patient With and Without Excessive Lag Screw Sliding Distance
Time frame: Postoperative 2-3 week
Number of patient was counted based on CT measurement results. Relative position of lag screw between CT images taken at both immediate and 2-3 weeks postoperatively was measured and recorded in value (e.g., 1.5 mm). This was called as "lag screw sliding distance". Four millimeter was set as threshold to define success and failure. Less than 4mm of lag screw sliding distance was recognized as Success and equal to or more than 4mm of lag screw sliding distance was recognized as Failure.
3 secondary outcomes
Surgery Time
Time frame: Intraoperative, an average of 1 hour
Image Assessment Using Computed Tomography (CT)
Time frame: 2-3 weeks postoperatively
Intraoperative Safety
Time frame: Intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Takashi Maehara, MD, Ph. D principal investigator
Kagawa Rosai Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Reduction and Internal Fixation, ZNN CM Asia and Anterior Support Screw in people with Trochanteric Fracture of Femur, run by Zimmer Biomet at 12 sites in Japan.
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 7 inclusion and 3 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patient With and Without Excessive Lag Screw Sliding Distance (time frame: Postoperative 2-3 week). 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 29 Sep 2020; AzTrials last refreshed its copy on 29 Oct 2026.