Trial document




drksid header

  DRKS00014369

Trial Description

start of 1:1-Block title

Title

"Prospective, open-label, multicentre, non-randomized, non-interventional, exploratory, comparative, uncontrolled Post Market Clinical Follow-Up Study of the Modular Revision Support (MRS)-Titan® Comfort"

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

2015-01-MRS-C

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

An observational study over a period of 5 years after implantation of a MRS-TITAN Comfort hip endoprosthesis.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A prospective, open, multicentre, non-randomized, non-interventional, explorative, comparative, uncontrolled cohort study with a CE-marked medical device within market observation (PMCF) for the systematic acquisition of clinical data from 120 patients with follow-up monitoring duration of 5 years or until revision (defined as implant replacement in whole or in part) of the implant.
Within this PMCF study, patient-relevant outcome measures (outcomes) are followed by a follow-up of the disease and treatment-related changes in relation to the medical prognosis over a period of 5 years after primary care or revision with the total hip arthroplasty system (TEP) MRS TITAN Comfort with the following goals:
a) Recovery of hip function / hip mobility
b) pain control
c) the safety of the implant as compatibility (type and number of notifiable and not reportable occurrences of all kinds) and lifetime of the hip endoprosthesis
d) Justification and time until a (re-)revision of the implant (defined as a change of implant in whole or in part)

The study duration of 5 years after implantation of the hip TEP covers the period in which most revisions (defined as implant replacement in whole or in part) of an implanted endoprosthesis are performed.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014369
  •   2018/06/29
  •   [---]*
  •   no
  •   Approved
  •   095/18, Ethik-Kommission der Medizinischen Fakultät der Rheinischen Friedrich-Wilhelms-Universität Bonn
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M16 -  Coxarthrosis [arthrosis of hip]
  •   M87 -  Osteonecrosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Arm 1: According to European Commission MedDev 2.12./2 this prospective PMCF study observes patients undergoing implantation of an MRS-C Hip Endoprosthesis over a 5-year follow-up period or until revision (defined as complete or partial explantation of the implant) of the implant. Demographic, safety and benefit / performance data are collected at different times: PRE (baseline) before implantation (surgery; OP), intraoperatively, 6th FU-month (after surgery), 1st FU-year (after surgery) , 2 FU-year (after surgery), 5th FU-year after implantation / OP. The patients are divided into 2 cohorts (Paprosky type I or type IIa, IIb, IIc or Paprosky type III a / b).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Patient-relevant endpoint after 5 years follow-up Duration with compliance criteria:
• Implant function verified by the HHS (Harris Hip Score) questionnaire completed by the examiner (improvement of at least 10 points compared to "PRÄ")

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

• Course of the HHS (Harris Hip Score) score: PRE (basic value), 6th FU-month, 1st FU-year, 2nd FU-year
• Course of the HOOS score (Hip disability and Osteoarthritis Outcome Score) + SF-36 (quality of life / restoration of function and reduction of pain from the patient's point of view): PRE (base value), 6th FU month, 1st FU year, 2 FU year, 5th FU year
• Number and type of events of all kinds (adverse events etc.)
• Number and reasons for a revision of the MRS-TITAN® Comfort (defined as implant replacement, in whole or in part) due to:
o infection
o (aseptic) relaxation
o other reasons (for example, allergy)
o a failure of the endoprosthesis, which is not due to quality defects * (for example, in an accident)
o Number of signs of implant loosening due to quality defects *
o Number of revisions of the implant (defined as replacement of the implant in whole or in part) due to quality defects *

(* Quality deficiency is for example material fatigue)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2020/03/10
  •   120
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

• Congenital or acquired hip joint defects
• Arthrosis (degenerative, rheumatic)
• Joint replacement (revision) already carried out and worn or in case of failed surgery
• Defect of the geometric rotation center
• Defects or malfunctions of the hip joint
• Post-traumatic arthritis
• Severe deformities (e.g. osteomyelitis)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

• Obesity or overweight of the patient
• Acute or chronic infections near the implantation
• All cases in which a stable anchoring of the implant cannot be achieved
• Diseases that impair bone growth such as cancer, renal dialysis, osteopenia, etc.
• Sensitivity to foreign matter in the implant materials
• Bone tumors in the area of the implant anchoring
• Illnesses which can be treated without using a hip implant
• Lack of patient cooperation
• Abuse of medication, drug abuse, alcoholism or mental disease
• Pregnancy
• Serious damage to the bone structures, which might endanger stable implantation of the implant components (at least 1 mandrel screw)
• Systemic diseases and metabolic disorders
• Overload of the hip implant to be expected
In justified cases in which, despite one of the contra-indications described above, an implantation is considered to be medically necessary, the following must be observed:
• The load capability of the material used in the device and for the fixation is limited.
• Contra-indications must be reduced as far as possible.

• Patients younger than 18 years
• Participate in another clinical trial and receive / use experimental or unauthorized medicines or medical devices.
• Existing disease of the other (unscheduled) hip with planned (surgical) intervention within the next 12 months.
• Patients who can be put under pressure to volunteer.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • PETER BREHM GmbH
    • Am Mühlberg 30
    • 91085  Weisendorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • PETER BREHM GmbH
    • Mr.  Dr.  Timo  Abbe 
    • Am Mühlberg 30
    • D-91085  Weisendorf
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • PETER BREHM GmbH
    • Mr.  Dr.  Timo  Abbe 
    • Am Mühlbach 30
    • D-91085  Weisendorf
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • PETER BREHM GmbH
    • Am Mühlberg 30
    • 91085  Weisendorf
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.