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
- Conditions
- M16M87Coxarthrosis [arthrosis of hip]Osteonecrosis
- Registration Number
- DRKS00014369
- Lead Sponsor
- PETER BREHM GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting withdrawn before recruiting started
- Sex
- All
- Target Recruitment
- 120
• 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)
• 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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-relevant endpoint after 5 years follow-up Duration with compliance criteria:<br>• Implant function verified by the HHS (Harris Hip Score) questionnaire completed by the examiner (improvement of at least 10 points compared to PRÄ)
- Secondary Outcome Measures
Name Time Method • Course of the HHS (Harris Hip Score) score: PRE (basic value), 6th FU-month, 1st FU-year, 2nd FU-year<br>• 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<br>• Number and type of events of all kinds (adverse events etc.)<br>• Number and reasons for a revision of the MRS-TITAN® Comfort (defined as implant replacement, in whole or in part) due to:<br>o infection<br>o (aseptic) relaxation<br>o other reasons (for example, allergy)<br>o a failure of the endoprosthesis, which is not due to quality defects * (for example, in an accident)<br>o Number of signs of implant loosening due to quality defects *<br>o Number of revisions of the implant (defined as replacement of the implant in whole or in part) due to quality defects *<br><br>(* Quality deficiency is for example material fatigue)