Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT01954433
Eligibility Criteria:
Inclusion Criteria:
* Male and female patient aged 18 years and over
* Patient willing and able to give written informed consent to participate in the study including all pre-surgical and post-surgical follow-up examinations
* Patient authorizing that their health insurance be contacted to provide health-related costs for the purpose of this study
Specific inclusion Criteria:
TSA:
* patients diagnosed with primary or secondary glenohumeral arthritis and/or rotator cuff tear arthropathy
* indicated for treatment with a total anatomic or reverse shoulder prosthesis or
RCR:
* patients diagnosed with partial or complete rotator cuff tear
* indicated for rotator cuff reconstruction by arthroscopy
or
TMC OA:
* patients diagnosed with TMC OA
* indicated for surgical treatment by resection interposition suspension arthroplasty of the TMC joint
Exclusion Criteria:
* General medical contraindication to surgery
* Revision operations
* Known hypersensitivity to the materials used
* Tumour / malignoma
* Addiction or other disorders (e.g. neuromuscular, psychiatric or metabolic disorder) that would preclude accurate evaluation
* Recent history of substance abuse
* Legal incompetence
* Pregnant women
* Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study
Specific exclusion Criteria:
* Other joints operated in the same session, except arthrodesis of the metacarpophalangeal (MCP) I joint
* Patients with rheumatoid arthritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01954433
Study Brief:
Protocol Section:
NCT01954433