Diaphyseal or Distal Femur Fracture Clinical Trial
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
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.
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 visit/Pre-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 patient's 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 Score(49;50)),
concomitant medications, fracture characteristics and accident/injury 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 investigator(s) will permit registry-related monitoring, audits, ethics
committee review and regulatory inspection(s), thereby providing direct access to the
facilities, personnel and to source data/documents on request. The Sponsor's 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 Sponsor's 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 investigator/s will be informed in writing and/or 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 Sponsor's 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
patient's 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 patient's clinical/medical 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 (i.e. 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 investigator(s) 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 and/or 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.
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Observational Model: Cohort, Time Perspective: Prospective