Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02656628
Status:
WITHDRAWN
Last Update Posted:
2016-01-21
First Post:
2014-07-04
Brief Title:
Observational Patient Registry of the Dynamic Locking Screws
Sponsor:
Synthes GmbH
Organization:
Synthes GmbH
Study Overview
Official Title:
A Multi-Center Prospective Observational Patient Registry of the Dynamic Locking Screws in Metaphyseal and Diaphyseal Shaft Fractures of the Humerus Femur and Tibia
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the voluntary recall of the study device DLS 37mm and DLS 50mm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DLS
Brief Summary:
The purpose of this multi-center patient registry is to obtain first clinical results and to assess short and mid-term clinical outcome data of patients treated with DLS
Detailed Description:
This is a multicenter open-label non-comparative observational patient registry conducted at 15 to 20 clinical sites
Patients who have agreed participate and have signed an informed patient consent prior to surgery will be included Follow-up visits will be performed at the following time points baseline pre-and postoperative at 6 weeks 12 weeks 6 months and 12 months for patients with insufficient signs of healing at the 6 months visit otherwise preferable visit
To minimize potential bias of the observational study design a reasonable sample of investigators and sites 15-20 sites and patients up to 200 patients are selected Furthermore data will be analyzed by an independent Contract Research Organization and objective outcome measures are used eg WOMAC QuickDASH fracture healing
All data collected on the electronic case report forms eCRF for this registry will be de-identified Each patient will be assigned to a unique reference number eCRFs are confidential documents and will only be available to the Sponsor including Sponsor delegates like clinical research associates CRAs the Investigator the investigation statistician and if requested to the advisory committee ethical committees and regulatory authorities The key to link the unique reference number to the patient will be kept in the investigation file by the Principal Investigator for each investigation site
Registry procedures
Baseline visitPre-Op
Potential study patients are informed about the study by the Investigator or delegate
All inclusion and exclusion criteria are checked to determine if the patient can participate in the registry
Prior to any registry-specific examination the patient gives written informed consent IC and the IC form is placed into the patients medical record A copy of the IC and the written patient information is handed over to the patient
Collection of demographic data medical history Charlson Comorbidity Score4950 concomitant medications fracture characteristics and accidentinjury information
Collection of X-rays all imaging procedures are organized and prepared for the transmission to the Clinical Research Organization CRO as outlined in the imaging manual
Documentation of study-specific questionnaires QuickDASH WOMAC EQ-5D based on the reported pre-injury status
The data are entered into the eCRF
Intra- and postoperative procedures
All surgical procedures will be done per the standard of care at the treating institution Aftercare and rehabilitation procedures will be left to the surgeons discretion
Follow-up visits
Post-operative before hospital discharge
6 weeks 7 - 56 days
12 weeks 57 - 120 days
6 month 121 -270 days
12 month 271 - 425 for patients with insufficient signs of healing at the 6 months visit otherwise preferable visit
The following procedures are performed during these visits
Assessment of fracture healing
Assessment of physical function and symptoms QuickDASH WOMAC weight bearing or load on the affected extremity status
Screening for AE or serious AE including documentation and reporting
Documentation and reporting of secondary surgical interventions due to device or procedure related Adverse events
Assessment of health-related quality of life EQ-5D
Collection of X-rays
Data entry into the eCRF
Appointment for the next visit
Clinical Investigation Administration
The clinical investigators will permit registry-related monitoring audits ethics committee review and regulatory inspections thereby providing direct access to the facilities personnel and to source datadocuments on request The Sponsors staff or representatives will closely monitor the conduct of the registry so that any questions and problems that may arise can be promptly resolved Such monitoring will also ensure that the registry is conducted in accordance with this registry protocol including all amendments and with the requirements of national regulations and ISO 14155
Monitoring will involve periodic visits by the Sponsors representative to the investigation site to verify compliance with all requirements of the registry to observe procedures and to audit the registry for quality control purposes presence of required documents informed consent and for comparison of the case report forms with source data The frequency of these periodic visits will depend on the enrolment rate and whether there are any difficulties in running the registry in a given site A monitoring plan describes all monitoring procedures in detail
On-site audits may take place and are independent of and separate from routine monitoring or quality control functions They may take place at various stages during the registry The clinical investigators will be informed in writing andor by telephone in a timely manner that an independent audit is to take place along with the scope of the audit a date and timelines involved Whenever possible the auditor will be accompanied by the responsible CRA or Sponsors representative The auditor may stay at the registry site as long as deemed necessary
In order to ensure quality of the data all relevant registry documents registry protocol case report forms patient information will be reviewed by a person not involved in the set-up and management of the registry The results of the audit will be documented in an audit report and any corrective actions needed from the Investigator communicated to the Principal Investigator
In general data collected in the hospital patient charts are considered as source data In order to facilitate data collection at the investigation sites a set of source worksheets SW based on all variables outlined in the registry protocol will be provided Data that is not routinely documented in the hospital chart is collected on these worksheets and therefore the worksheet is considered to be the source document and has to be kept at the investigation site accordingly Data collected on patient and surgeon questionnaires are also considered as source data
Source data will be entered by site staff into a web-based Electronic Data Capture EDC system and managed according to a detailed pre-specified Data Management Plan The Investigator or site coordinator shall complete the eCRF in a timely manner after a patients visit ie not later than 10 days after the occurrence of a documentable event
Completed eCRFs will be verified against source data ie source data verification
Investigators shall provide access to the hospital files and any other medical source document containing patients clinicalmedical information to the company representative to allow source document verification
The clinical Investigator is asked to keep a list with full names of all patients participating in the registry giving reference to the patient records
After the completion of the registry an electronic copy of the data collected at each investigation clinic will be provided
Radiographic images will be collected as per standard imaging procedures standard of care at the investigation site following patient examinations at discharge 6 and 12 weeks 6 and 12 months Digital de-identified images will be sent to GCTM Transfer of imaging data to GCTM and handling of the de-identified imaging data at GCTM will be performed according to GCTM standard procedures More details are described in the imaging manual
Images relevant for the registry will be retained de-identified electronically as part of the TMF in accordance with relevant guidelines
The central registry database will be monitored by GCTM representative and queries will be made on a regular basis to each participating site as needed to ensure the quality and integrity of the data
Data management will be performed by GCTM Data handling and protection are conducted according to the guidelines of International Organization for Standardization ISO 14155 and applicable regulations
A study specific Data Management Plan describes all details of data management and quality control of the study database at GCTM
All trial-related essential documents ie documents which individually and collectively permit evaluation of the conduct of an observational study and the quality of the data produced will be retained by the clinical Investigator for at least 15 years after the end of the registry or as per national requirements In case where this is not possible the Sponsor will organize archiving facilities for the source data in accordance with data confidentiality regulations The Sponsor will inform the clinical investigators in writing when these documents no longer need to be retained
The Sponsor will retain specific essential documents in the Trial Master File TMF according to the relevant guidelines
The Principal Investigator at each investigation site has the primary responsibility for patients treatment follow-up and overall compliance with the registry protocol national regulatory requirements and the requirements of ISO 14155 It is advisable that the investigation site appoints a study coordinator who can become the primary point of contact for the CRA concerning overall registry administrative matters
All Investigators using the DLS in the registry must be trained on the registry device the registry protocol requirements national regulations and requirements of the ISO 14155 prior to becoming involved in the patient registry and include their curriculum vitae CV in the Investigator file with a copy for the Sponsor TMF This training shall be documented by the CRA andor the Principal Investigator on the site personnel log along with the authorized tasks the Principal Investigator delegates to each team member and an identification of signature
The registry obligations for the Sponsor the Clinical Research Associate and the Investigator are followed as outlined in the ISO14155 and any applicable regulation and reviewed with the Investigator prior to the start of the registry
Patients who have agreed participate and have signed an informed patient consent prior to surgery will be included Follow-up visits will be performed at the following time points baseline pre-and postoperative at 6 weeks 12 weeks 6 months and 12 months for patients with insufficient signs of healing at the 6 months visit otherwise preferable visit
To minimize potential bias of the observational study design a reasonable sample of investigators and sites 15-20 sites and patients up to 200 patients are selected Furthermore data will be analyzed by an independent Contract Research Organization and objective outcome measures are used eg WOMAC QuickDASH fracture healing
All data collected on the electronic case report forms eCRF for this registry will be de-identified Each patient will be assigned to a unique reference number eCRFs are confidential documents and will only be available to the Sponsor including Sponsor delegates like clinical research associates CRAs the Investigator the investigation statistician and if requested to the advisory committee ethical committees and regulatory authorities The key to link the unique reference number to the patient will be kept in the investigation file by the Principal Investigator for each investigation site
Registry procedures
Baseline visitPre-Op
Potential study patients are informed about the study by the Investigator or delegate
All inclusion and exclusion criteria are checked to determine if the patient can participate in the registry
Prior to any registry-specific examination the patient gives written informed consent IC and the IC form is placed into the patients medical record A copy of the IC and the written patient information is handed over to the patient
Collection of demographic data medical history Charlson Comorbidity Score4950 concomitant medications fracture characteristics and accidentinjury information
Collection of X-rays all imaging procedures are organized and prepared for the transmission to the Clinical Research Organization CRO as outlined in the imaging manual
Documentation of study-specific questionnaires QuickDASH WOMAC EQ-5D based on the reported pre-injury status
The data are entered into the eCRF
Intra- and postoperative procedures
All surgical procedures will be done per the standard of care at the treating institution Aftercare and rehabilitation procedures will be left to the surgeons discretion
Follow-up visits
Post-operative before hospital discharge
6 weeks 7 - 56 days
12 weeks 57 - 120 days
6 month 121 -270 days
12 month 271 - 425 for patients with insufficient signs of healing at the 6 months visit otherwise preferable visit
The following procedures are performed during these visits
Assessment of fracture healing
Assessment of physical function and symptoms QuickDASH WOMAC weight bearing or load on the affected extremity status
Screening for AE or serious AE including documentation and reporting
Documentation and reporting of secondary surgical interventions due to device or procedure related Adverse events
Assessment of health-related quality of life EQ-5D
Collection of X-rays
Data entry into the eCRF
Appointment for the next visit
Clinical Investigation Administration
The clinical investigators will permit registry-related monitoring audits ethics committee review and regulatory inspections thereby providing direct access to the facilities personnel and to source datadocuments on request The Sponsors staff or representatives will closely monitor the conduct of the registry so that any questions and problems that may arise can be promptly resolved Such monitoring will also ensure that the registry is conducted in accordance with this registry protocol including all amendments and with the requirements of national regulations and ISO 14155
Monitoring will involve periodic visits by the Sponsors representative to the investigation site to verify compliance with all requirements of the registry to observe procedures and to audit the registry for quality control purposes presence of required documents informed consent and for comparison of the case report forms with source data The frequency of these periodic visits will depend on the enrolment rate and whether there are any difficulties in running the registry in a given site A monitoring plan describes all monitoring procedures in detail
On-site audits may take place and are independent of and separate from routine monitoring or quality control functions They may take place at various stages during the registry The clinical investigators will be informed in writing andor by telephone in a timely manner that an independent audit is to take place along with the scope of the audit a date and timelines involved Whenever possible the auditor will be accompanied by the responsible CRA or Sponsors representative The auditor may stay at the registry site as long as deemed necessary
In order to ensure quality of the data all relevant registry documents registry protocol case report forms patient information will be reviewed by a person not involved in the set-up and management of the registry The results of the audit will be documented in an audit report and any corrective actions needed from the Investigator communicated to the Principal Investigator
In general data collected in the hospital patient charts are considered as source data In order to facilitate data collection at the investigation sites a set of source worksheets SW based on all variables outlined in the registry protocol will be provided Data that is not routinely documented in the hospital chart is collected on these worksheets and therefore the worksheet is considered to be the source document and has to be kept at the investigation site accordingly Data collected on patient and surgeon questionnaires are also considered as source data
Source data will be entered by site staff into a web-based Electronic Data Capture EDC system and managed according to a detailed pre-specified Data Management Plan The Investigator or site coordinator shall complete the eCRF in a timely manner after a patients visit ie not later than 10 days after the occurrence of a documentable event
Completed eCRFs will be verified against source data ie source data verification
Investigators shall provide access to the hospital files and any other medical source document containing patients clinicalmedical information to the company representative to allow source document verification
The clinical Investigator is asked to keep a list with full names of all patients participating in the registry giving reference to the patient records
After the completion of the registry an electronic copy of the data collected at each investigation clinic will be provided
Radiographic images will be collected as per standard imaging procedures standard of care at the investigation site following patient examinations at discharge 6 and 12 weeks 6 and 12 months Digital de-identified images will be sent to GCTM Transfer of imaging data to GCTM and handling of the de-identified imaging data at GCTM will be performed according to GCTM standard procedures More details are described in the imaging manual
Images relevant for the registry will be retained de-identified electronically as part of the TMF in accordance with relevant guidelines
The central registry database will be monitored by GCTM representative and queries will be made on a regular basis to each participating site as needed to ensure the quality and integrity of the data
Data management will be performed by GCTM Data handling and protection are conducted according to the guidelines of International Organization for Standardization ISO 14155 and applicable regulations
A study specific Data Management Plan describes all details of data management and quality control of the study database at GCTM
All trial-related essential documents ie documents which individually and collectively permit evaluation of the conduct of an observational study and the quality of the data produced will be retained by the clinical Investigator for at least 15 years after the end of the registry or as per national requirements In case where this is not possible the Sponsor will organize archiving facilities for the source data in accordance with data confidentiality regulations The Sponsor will inform the clinical investigators in writing when these documents no longer need to be retained
The Sponsor will retain specific essential documents in the Trial Master File TMF according to the relevant guidelines
The Principal Investigator at each investigation site has the primary responsibility for patients treatment follow-up and overall compliance with the registry protocol national regulatory requirements and the requirements of ISO 14155 It is advisable that the investigation site appoints a study coordinator who can become the primary point of contact for the CRA concerning overall registry administrative matters
All Investigators using the DLS in the registry must be trained on the registry device the registry protocol requirements national regulations and requirements of the ISO 14155 prior to becoming involved in the patient registry and include their curriculum vitae CV in the Investigator file with a copy for the Sponsor TMF This training shall be documented by the CRA andor the Principal Investigator on the site personnel log along with the authorized tasks the Principal Investigator delegates to each team member and an identification of signature
The registry obligations for the Sponsor the Clinical Research Associate and the Investigator are followed as outlined in the ISO14155 and any applicable regulation and reviewed with the Investigator prior to the start of the registry
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None