bone defect with indication for surgical treatment (filling or fusion)
Conditions
Interventions
Group 1: patients who are planned to get either bone fusion surgery or a bone void filling of a surgically created defect
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • The patient (male or female) must be 18 years or older • The patient must be a candidate for treatment of bone defects in aforementioned the indications • If patient is of child-bearing potential, the patient confirms not to be pregnant • The patient is able to comply with the clinical investigation -related procedures such as attending all follow-up procedures • The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent including the use of the anonymized data for scientific publication • The patient will not participate in another clinical investigation during this clinical investigation
Exclusion criteria
Exclusion criteria: • General contraindications for surgical treatment are present • The patient has a history of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years • The patient is currently being treated with radiation, chemotherapy, immunosuppression or steroid therapy dose equivalent of more than 5mg prednisolon • The patient is pregnant or nursing • Women of childbearing age who are not using a highly effective method of birth control • The patient has acute or chronic infection at the surgical site • The patient has a known allergy to collagen and/or bovine bone material • The patient has a medical history of alcohol or drug abuse within the last year prior to the screening examination • Vulnerable population • Patient is currently participating, or has participated in another clinical investigation within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endopoint is the safety of Orthoss® Collagen as a bone void filler, defined as the absence of local or systemic Serious Adverse Event (SAE) related to to the medical device 3 months post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the performance of the Orthoss® Collagen defined as bone integration at 12 months post-operatively. | — |
Countries
Germany
Contacts
Public ContactMarkus Walther
Schön Klinik München Harlaching
Outcome results
None listed