Trial document





This trial has been registered retrospectively.
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  DRKS00012994

Trial Description

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Title

German speaking Arthroscopy Registry

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Trial Acronym

DART

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URL of the Trial

http://www.arthroskopieregister.de/

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Brief Summary in Lay Language

The German speaking Arthroscopy Registry is a web-based platform for quality management and outcome research in the field of minimal invasive joint surgery. To fulfill the aims of the registry patients will be provided with outcome questionnaires 6, 12, 24, 36, 52 and 120 after surgery via email links.

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Brief Summary in Scientific Language

The German speaking Arthroscopy Registry is a web-based platform for quality management and outcome research in the field of arthroscopic joint surgery. To fulfill the aims of the registry patients will be provided with outcome questionnaires 6, 12, 24, 36, 52 and 120 after surgery via email links. These questionnaires include validated functional scores, activity scores and QOL scores. Surgeons will describe the individual pathology, process of surgery and perioperative management by a questionnaire.

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Organizational Data

  •   DRKS00012994
  •   2018/01/09
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  •   no
  •   Approved
  •   Eth-26/17, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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Health Condition or Problem studied

  •   S40-S49 -  Injuries to the shoulder and upper arm
  •   S50-S59 -  Injuries to the elbow and forearm
  •   S60-S69 -  Injuries to the wrist and hand
  •   S70-S79 -  Injuries to the hip and thigh
  •   S80-S89 -  Injuries to the knee and lower leg
  •   S90-S99 -  Injuries to the ankle and foot
  •   T00-T07 -  Injuries involving multiple body regions
  •   T80-T88 -  Complications of surgical and medical care, not elsewhere classified
  •   M00-M25 -  Arthropathies
  •   M80-M94 -  Osteopathies and chondropathies
  •   M95-M99 -  Other disorders of the musculoskeletal system and connective tissue
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Interventions/Observational Groups

  •   The arthroscopic procedure will be performed as part of the routine management. Suitable patients will be informed by the surgeon. After the patient has given informed consent medical data will be provided by the patient via questionnaires 6, 12, 24, 36, 60 and 120 months after surgery. The time to answer each questionnaire will be approximately 15-20 minutes. Each study site can choose from two ways of data input: quality management (basic) and health care science (science). Since quality management primarily aims for internal quality issues or communication with health care authorities no ethical approval is needed. However the patients need to sign the patient informed consent, mainly for data protection reasons. Data from the quality management tool will not be used for scientific publication. In contrast, each site which enters data into the science part needs an ethical approval.
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Characteristics

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

Primary outcome knee: Therapy response defined as reduction of 8 or more points in the KOOS (knee injury and osteoarthritis outcome score) after 24 months.
Primary outcome hip joint: iHot 12 (International Hip Outcome Tool, short version) after 24 months
Primary outcome ankle joint: Therapy response defined as reduction of 8 or more points in FAAM (Foot and Ankle Ability Measure) after 24 months.
Primary outcome shoulder: Therapy response defined as reduction of 12 or more points in American Shoulder and Elbow Surgeon's Standardized Shoulder Assessment Form (ASES) for RM rupture and 9 points or more for prostheses.

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Secondary Outcome

Secondary outcomes knee: KOOS after 6, 12, 36, 60 and 120 months, VAS (Visual Analogue Scale) after 6, 12, 24, 36, 60 and 120 months, EQ5D (health-related quality of life questionnaire) after 6, 12, 24, 36, 60 and 120 months, Marx Score (Marx Activity Rating Scale) after 6, 12, 36, 60 and 120 months
Secondary outcomes hip joint: iHot 12 after 6, 12, 36, 60 and 120 months, VAS after 6, 12, 24, 36, 60 and 120 months, EQ5D after 6, 12, 24, 36, 60 and 120 months, Marx score after 6, 12, 36, 60 and 120 months.
Secondary outcomes ankle joint: FAAM after 6, 12, 36, 60 and 120 months, VAS after 6, 12, 24, 36, 60 and 120 months, EQ5D after 6, 12, 24, 36, 60 and 120 months, Marx score after 6, 12, 36, 60 and 120 months.
Secondary outcomes shoulder: Oxford Shoulder Score or ASES after 6, 12, 36, 60 and 120 months, VAS after 6, 12, 24, 36, 60 and 120 months, EQ5D after 6, 12, 24, 36, 60 and 120 months, Marx Score after 6, 12, 36, 60 and 120 months

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Countries of Recruitment

  •   Germany
  •   Switzerland
  •   Austria
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2017/11/09
  •   5000
  •   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

- Male and female patients aged ≥ 18 years
- Patients with arthroscopic joint surgery of the knee, hip, ankle or shoulder
- Patients who give their written informed consent
- Patients who are able to understand the nature, significance and consequences of the trial
- Patients with a valid e-mailaddress

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Exclusion Criteria

No exclusion criteria specified

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Addresses

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    • Deutschsprachiges Arthroskopieregister gGmbH (DART gGmbH)
    • Breite Straße 96
    • 41460  Neuss
    • Germany
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    • Deutschsprachiges Arthroskopieregister gGmbH (DART gGmbH)
    • Mr.  Priv.-Doz. Dr. med.  Ralf  Müller-Rath 
    • Breite Straße 96
    • 41460  Neuss
    • Germany
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    • Deutschsprachiges Arthroskopieregister gGmbH (DART gGmbH)
    • Mr.  Priv.-Doz. Dr. med.  Ralf  Müller-Rath 
    • Breite Straße 96
    • 41460  Neuss
    • Germany
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Sources of Monetary or Material Support

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    • AGA - Gesellschaft für Arthroskopie und Gelenkchirurgie (Deutschsprachige Arbeitsgemeinschaft für Arthroskopie)
    • 1090  Wien
    • Austria
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    • Berufsverband für Arthroskopie e.V.
    • 41460  Neuss
    • Germany
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    • GOTS - Gesellschaft für Orthopädisch-Traumatologische Sportmedizin
    • 07749  Jena
    • Germany
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    • DGOU - Deutsche Gesellschaft für Orthopädie und Unfallchirurgie
    • 10623  Berlin
    • Germany
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    • Arthrex GmbH
    • 81249  München
    • Germany
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    • Smith & Nephew GmbH
    • 22763  Hamburg
    • Germany
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    • medi GmbH & Co. KG
    • 95448  Bayreuth
    • Germany
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    • Juzo - Julius Zorn GmbH
    • 86551  Aichach
    • Germany
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    • DJO Global - ORMED GmbH
    • 79100  Freiburg
    • Germany
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    • DIZG - Deutsches Institut für Zell- und GewebeersatzGemeinnützige Gesellschaft mbH
    • 12555  Berlin
    • Germany
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    • OPED GmbH
    • 83626  Valley
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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