DRKS00018809
Recruiting
Not Applicable
A post market clinical follow-up study with the aneXys ceramys inlay DE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- M16.7
- Sponsor
- Mathys Orthopädie GmbH
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •\- Informed consent form (signed by participant and investigator)
- •\- Primary implantation
- •\- Suffer from primary or secondary osteoarthritis of the hip, femoral head and neck fractures or necrosis of the femoral head. In all cases a stable anchoring of the implant has to be possible.
- •\- Age at inclusion: between 18 and 75 years old
- •\- Willing to participate in the follow\-up examinations mentioned above
- •\- Complete recovery is expected
Exclusion Criteria
- •The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- •\- Missing informed consent form (signed by participant and investigator)
- •\- Known or suspected non\-compliance (e.g. drug or alcohol abuse)
- •\- Enrolment of the investigator, his/her family, employees and other dependent persons
- •\- Patients younger 18 years old
- •\- Revision surgery
- •\- Presence of sepsis or malignant tumours
- •\- ASA (American Society of Anesthesiologists) Classification \>3
- •\- Pregnancy
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A post market clinical follow-up study with the aneXys acetabular cup and ceramys inlayM16.1M16.7Other primary coxarthrosisOther secondary coxarthrosisDRKS00021508Mathys AG Bettlach150
Completed
Not Applicable
Post-market clinical follow-up study evaluating the efficacy and safety of the wearable cardioverter-defibrillator (WCD) medical device 'LifeVest' in real-life settings in FranceISRCTN91372291ZO550
Recruiting
Phase 4
Thigh bone fracture and its union by using different implants studyHealth Condition 1: O- Medical and SurgicalCTRI/2024/01/061265Auxein Medical Pvt Ltd
Completed
Phase 4
A post market clinical follow up study of Sterile Hydroxy Propyl Methyl Cellulose Eye DropsHealth Condition 1: H579- Unspecified disorder of eye and adnexaCTRI/2024/02/062930Amanta Healthcare Limited65
Completed
Phase 4
The purpose of the study is to evaluate safety and performance of Eye Preparations- Hypromellose plus Sodium Hyaluronate Eye Drops.Health Condition 1: H28- Cataract in diseases classified elsewhereCTRI/2022/07/043789STERICON PHARMA PRIVATE LIMITED54