Trial document





This trial has been registered retrospectively.
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  DRKS00013521

Trial Description

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Title

ENDOprosthetic joint replacement

improving treatment by integrating Prehabilitation, Rehabilitation, Individualized Management and Education

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Trial Acronym

EndoPRIME

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of long term results after total joint replacement in patients receiving individualized management, prehabilitation and rehabilitation.

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Brief Summary in Scientific Language

We hypothesize that patient reported outcome, the frequency of untoward events and functional outcome following total joint replacement of the hip, knee and shoulder can be improved by establishing an individualized pre- and postoperative treatment pathway based on an elaborate preoperative medical evaluation including a comprehensive musculoskeletal assessment and risk factor evaluation.

Interventions comprise instructed exercise before and after surgery, patient education and enhanced medical care

Assessments focus on Quality of life using established questionnaires and ability to walk

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013521
  •   2018/01/15
  •   [---]*
  •   yes
  •   Approved
  •   214/14, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

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Health Condition or Problem studied

  •   M16.0 -  Primary coxarthrosis, bilateral
  •   M17.0 -  Primary gonarthrosis, bilateral
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Interventions/Observational Groups

  •   Targeted risk assessment by means of a structured musculoskeletal examination preoperatively
    - Short Physical Performance Battery (SPPB)
    - Handheld Dynamometry
    - Gait Speed
    - Osteoporosis Risk factors (DVO-Guidelines)
    - Risk of infection
    - Assessment of muscular deficits and dysbalances

    Individual Prehabilitation Exercise Plan for each participant for 3 months of preparation before surgery. Follow-up evaluations at 1 day before and 3/6/12 months after surgery.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Intraindividual development of osteoarthritis-associated health-limitations as measured by the WOMAC-Score before and 3/6/12 months after surgery

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Secondary Outcome

- Patient Reported Outcome, quantified by standardized questionaires
- Type and frequency of perioperative untoward events
- Improvement of quality of life in everyday life (EuroQol, PID, LEFS, IPAQ, VAS, CES-D)
- Improvement of strength and flexibility/mobility (Chair-Rising-Test, 6-Minute Walk Test, Gait Speed, Short Physical Performance Battery)
- Grip strength with dynamometer
- Ground reaction force measurement (Leonardo plate)
- Body composition (Bioimpedance Analysis)
- Satisfaction with artificial joint

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/04/25
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Adult males and females (age ≥ 18 years)
Established diagnosis of Osteoarthritis of the hip, knee or shoulder
Given medical indication for total joint replacement.

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Exclusion Criteria

Acute (< 3 months) or non-consolidated fractures;
Planed implantation of a custom-made prosthesis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinische StudieneinheitOrthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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    • Klinische StudieneinheitOrthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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    • König-Ludwig-Haus
    • Ms.  Silke  Achtziger 
    • Brettreichstraße 11
    • 97074  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinische StudieneinheitOrthopädische Klinik, Universität Würzburg
    • Mr.  Dr. med.  Lothar  Seefried 
    • Brettreichstraße 11
    • D-97074  Würzburg
    • Germany
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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.