M16 M87
Conditions
Interventions
Group 1: 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 u
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 typ
Sponsors
PETER BREHM GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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)
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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") | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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) | — |
Countries
Germany
Contacts
Public ContactTimo Abbe
PETER BREHM GmbH
Outcome results
None listed