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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open Reduction and Internal Fixation | Procedure | Fractured bone fragments are reduced and stabilized by intramedullary nail. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative 2-3 week |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Time | Surgery time from skin incision to closure | 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). |
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Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria.
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Takashi Maehara, MD, Ph. D | Kagawa Rosai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kure Kyosai Hospital | Kure | Hiroshima | 737-8505 | Japan | ||
| Toyooka Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | ZNN CM Asia With AS2 Technique | 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). Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. |
| FG001 | ZNN CM Asia Without AS2 Technique | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ZNN CM Asia With AS2 Technique | 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). Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Postoperative 2-3 week |
|
3 weeks after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ZNN CM Asia With AS2 Technique | 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). Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cut-out | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Proximal fracture fragment was dislodged after surgery and required reoperation to hemi hip replacement surgery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager of Clinical Affairs | Zimmer Biomet G.K. | +81-3-6402-6610 | takahito.nakai@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2016 | Sep 20, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070799 | Open Fracture Reduction |
| D005593 | Fracture Fixation, Internal |
| ID | Term |
|---|---|
| D005592 | Fracture Fixation |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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At surgery, intervention group using ZNN CM Asia with AS2 technique. At surgery, conventional group using ZNN CM Asia without AS2 technique.
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(Investigational group) or ZNN CM Asia without AS2 technique (Control group). The randomization scheme is based on equal numbers per group. The randomization will occur via a random number generator (computer) using a blocked randomization procedure. The block size will not be disclosed to the sites, and the doctor or other health care professional will not have influence on the randomization scheme. Sealed opaque envelopes, which will be prepared based on predetermined randomization assignment, will be provided to each study site before study initiation.
| ZNN CM Asia | Device | Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. |
|
| Anterior Support Screw | Device | Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. |
|
|
| 2-3 weeks postoperatively |
| Intraoperative Safety | This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred. | Intraoperative |
| Toyooka |
| Hyōgo |
| 668-8501 |
| Japan |
| Kasugai Municipal Hospital | Aichi | Kasugai | 486-8510 | Japan |
| Hoshigaoka Medical Center | Hirakata | Osaka | 573-8511 | Japan |
| Numazu City Hospital | Numazu | Shizuoka | 410-0302 | Japan |
| Saiseikai Takaoka Hospital | Takaoka | Toyama | 933-8525 | Japan |
| Kyushu Central Hospital | Fukuoka | 815-8588 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | 861-4193 | Japan |
| Niigata Central Hospital | Niigata | 950-8556 | Japan |
| Okayama Red Cross Hospital | Okayama | 700-8607 | Japan |
| Okayama Rosai Hospital | Okayama | 702-8055 | Japan |
| Saga Pref. Medical Centre Koseikan | Saga | 840-8571 | Japan |
| BG001 | ZNN CM Asia Without AS2 Technique | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | ZNN CM Asia Without AS2 Technique | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. |
|
|
| Secondary | Surgery Time | Surgery time from skin incision to closure | Posted | Mean | Standard Deviation | minutes | Intraoperative, an average of 1 hour |
|
|
|
| Secondary | 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). | Participants, whose immediate postoperative reduction position is assessed as either "Anterior" or "Neutral", were eligible. Eight patients in ZNN CM Asia with AS2 technique group and 6 patients in ZNN CM Asia without AS2 technique group were excluded from this analysis (their immediate postoperative reduction position was "Posterior".) | Posted | Count of Participants | Participants | 2-3 weeks postoperatively |
|
|
|
| Secondary | Intraoperative Safety | This is to evaluate whether any adverse events specific to insert additional screw for AS2 technique were occurred. | Intent-to-treat group | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| 0 |
| 121 |
| 1 |
| 121 |
| 0 |
| 121 |
| EG001 | ZNN CM Asia Without AS2 Technique | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. | 0 | 119 | 0 | 119 | 0 | 119 |
|
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