Trial document




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  DRKS00006758

Trial Description

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Title

A prospective and observational clinical investigation evaluating the clinical outcomes of unstable distal radius fractures treated by the dynamic external fixator Galaxy Wrist

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Trial Acronym

OCI 1401

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URL of the Trial

http://NA

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Brief Summary in Lay Language

In the present clinical study will be used the “Galaxy Wrist” which is an external fixator manufactured by Orthofix for the treatment of complicated wrist fractures.
Before to put the “Galaxy Wrist” on the market Orthofix performed a lot of test to be sure that the device is safe and clinically performing and obtained the CE mark. The “Galaxy Wrist” has been already used on many patients and this clinical study is aimed to collect data to confirm that the device is safe and clinically performing.
To collect enough data Orthofix planned to recruit 120 patients with complicated wrist fractures coming from Germany and Italy. Each patients should participate for a period of approximately 1 year in the study with 8 in planned visits this period. The planned visits are part of the normal clinical practice of the site, it means that the patient will have the same visits also in the case he/she will decide to not participate in the study and that the investigator will not perfom additional test on the patients.

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Brief Summary in Scientific Language

TYPE OF THE INVESTIGATION
Post market, observational, prospective, not randomized, not controlled, multicenter and international, namely a Post Market Clinical Follow-up study (PMCF).
INVESTIGATIONAL DEVICE
Galaxy Wrist (Orthofix Srl), an external dynamic fixator for unstable distal radius fractures (DRFs) treatment. Galaxy Wrist is available on the market in 2 different configurations, non-bridging and bridging, only the bridging configuration will be used in this investigation.
RATIONALE
Orthofix Srl developed the new articulated external fixator Galaxy Wrist and put it on the market.
The available clinical data on equivalent devices were appropriate to state the conformity of Galaxy Wrist to Essential Requirements and to obtain CE mark. The present observational clinical investigation has been planned as part of the post-market surveillance plan to update the pre-market clinical evaluation of the Galaxy Wrist with data arising from the full range of clinical condition encountered in general medical practice.
OBJECTIVES
To assess the clinical performance and the safety of Galaxy Wrist in treating/healing DRFs on a representative population of patients and users observed in the normal clinical practice conditions.
POPULATION
A total of 120 male or female adult patients who have been diagnosed with distal radius fracture(s) and having a regular indication for surgical intervention with a dynamic external fixator are planned to be enrolled to reach a representative population of 100 completed patients.
INVESTIGATIONAL SITES AND COUNTRIES
The study will be conducted in Italy and in Germany. A minimum of 6 sites and a maximum of 8 sites are planned to participate in the study. Accordingly it is expected that each site will recruit approximately 15 - 20 patients. The enrolment will be competitive between countries and sites.
PROCEDURES
During the pre-study visits it was assessed that the procedures reported in this CIP are currently considered as the normal clinical practice for all the participating investigational sites. This is an observational study, therefore it will not it will not intervene with the hospital standard of care guidelines and/or the internal therapeutic protocol. The planned visits are aimed to obtain as much as possible uniform results.
Before to participate in the study the Investigators, under their own responsibility, will complete the learning curve concerning the treatment of DRFs with Galaxy Wrist and will obtain a certified training on Good Clinical Practice. Moreover, before to enroll the first patient, the Investigators will be trained by the Sponsor on CIP contents, eCRF manual and safety related issues reporting.
The patients will be advised that participation in these investigations is voluntary. Before taking part in the study, each eligible patient will be informed on the study features, risks, benefits and responsibilities and will sign and date the appropriate ICF. A copy of the signed and dated ICF will be left to the patient.
During the recruitment period, each surgeon will consecutively include patients satisfying all inclusion criteria and no exclusion criteria. After the screening visit, according to the hospital current clinical practice of the hospital and to instruction for use provided by Orthofix Srl, the patients will undergo the surgery and then 6 following visits. The first 3 visits performed after the surgery (hospital discharge, device unlock and device removal) are part of the treatment period, whereas the remaining 3 visits are part of the follow up period (3 months, 6 months and 1 year). In case of premature discontinuation, the patient will maintain the right to all medical care as needed.
STUDY LIVE PHASE DURATION
Between 18 months and 21 months.
STUDY DURATION PER PATIENT
1 year since the informed consent signature to the final follow up visit

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Organizational Data

  •   DRKS00006758
  •   2014/09/25
  •   [---]*
  •   no
  •   Approved
  •   Bo/20/2014, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   S60-S69 -  Injuries to the wrist and hand
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Interventions/Observational Groups

  •   Patients who have been diagnosed with instable distal radius fracture(s) and which will be treated with the CE-certified medical device Galaxy Wrist, a dynamic external fixator, in the bridge configuration are investigated in this non-interventional study to obtain inforamtion about clinical performance and safety of the product.

    The evaluation is based on the following non-interventional clinical assessments: grip strength measurement by dynamometer (Dynamometer), determination of the "Patient-Rated Wrist Evaluation" (PRWE) number and the "Disabilities of the Arm, Shoulder and Hand '(DASH) rating number, review the "Investigational Medical Device deficiencies" (IMDDs), determine the range of motion of the wrist and the investigation of lateral pinch/ grip strength.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

OBJECTIVES
To assess the clinical performance and the safety of Galaxy Wrist in treating/healing DRFs on a representative population of patients and users observed in the normal clinical practice conditions.

EFFICACY ENDPOINTS
The clinical performance of Galaxy Wrist in treating/healing DRFs will be assessed by the following clinical efficacy endpoints:
- “Patient-Rated Wrist Evaluation” (PRWE) score (patientquestionnaire);
- range of wrist motion (ROM);
- grip strength;
- lateral pinch;
- “Disabilities of the Arm, Shoulder and Hand” (DASH) score (patientquestionnaire);
- radiographic measurements (Bohler angle in the anterior-posterior and lateral views)
- Visual Analogue Scale (VAS).

SAFETY ENDPOINTS
The safety of Galaxy Wrist in treating/healing DRFs will be assessed by the following safety endpoints:
- frequencies and the nature of the Serious Adverse Device Effects (SADEs);
- frequencies and the nature of the Adverse Device Effects (ADEs);
- frequencies and the nature of Investigational Medical Device Deficiencies (IMDDs).

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
  •   Italy
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/04
  •   120
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

INCLUSION CRITERIA
Patient will be eligible for inclusion in the investigation if he/she:
- is at least 18 years old at time of ICF signature;
- compliant to sign ICF;
- has a fresh (≤ 14 days since the time of the injury), intra- or extra-articular, unstable Distal Radius Fracture(s) (DRF(s)) with or without soft tissue damage requiring a surgical management;
- has a regular indication for surgical intervention with Galaxy Wrist, in the bridging configuration, up to the surgeon decision.

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Exclusion Criteria

EXCLUSION CRITERIA
Patient will be excluded from participation in the investigation if he/she:
- has bilateral DRFs;
- has carpal combined injuries/fractures;
- has rheumatoid arthritis;
- has previous DRF/arthrodesis;
- has a medical condition that is a contraindication according to the manufacturer instruction for use;
- has suspected foreign body sensitivity or declared allergy to the device components which contact the patient;
- has any conditions which in the Investigator’s opinion may interfere with the study execution or due to which the patient should not participate for safety reasons;
- is unwilling or incapable of following postoperative care instructions due to mental or physiological condition;
- is assuming a not permitted concomitant medication which cannot be safely stopped;
- is having a concomitant treatment with a not permitted devices which cannot be safely removed;
- is participating other clinical trials or took part to a clinical study in the last 3 months;
- is likely to be lost to follow up.

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Addresses

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    • Orthofix Srl, , Bussolengo (Verona), Italy
    • Mr.  Dr.  Mario  Dandrea (Clinical Research Coordinator) 
    • Via Delle Nazioni 9
    • 37012  Bussolengo (Verona)
    • Italy
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    • proinnovera GmbH (CRO)
    • Wienburgstraße 207
    • 48159  Münster
    • Germany
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    • Orthofix Srl, , Bussolengo (Verona), Italy
    • Mr.  Dr.  Mario  Dandrea (Clinical Research Coordinator) 
    • Via Delle Nazioni 9
    • 37012  Bussolengo (Verona)
    • Italy
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    • Klinikum OsnabrückKlinik für Orthopädie, Unfall und Handchirurgie
    • Dr  Casper  Grim 
    • Am Finkenhügel 1
    • 49076  Osnabrück
    • Germany
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Sources of Monetary or Material Support

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    • Orthofix Srl
    • Via Delle Nazioni 9
    • 37012  Bussolengo (Verona)
    • Italy
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.