Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04462458 |
| Other study ID # |
P07.001.01 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2022 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
March 2023 |
| Source |
Medacta International SA |
| Contact |
Denise Falcone |
| Phone |
+41916966060 |
| Email |
falcone[@]medacta.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery
(M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction.
The main goal is to evaluate the survival rate of M-ARS ACL at 6 months post-operatively. The
secondary goals are to assess the survival rate, clinical and functional outcomes, the
quality of life, and the rate of complications at 1 month, 1 year and 2 years
post-operatively.
Description:
This s a prospective, multicenter, non-controlled, observational study to evaluate the
outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior
cruciate ligament (ACL).
Participants will be informed about the study, both orally and in writing, during a
preoperative visit. The investigator will answer any questions that may arise and will
collect the informed consent. During the study, enrolled participants will be able to
withdraw at any time and for any reason.
The study is conducted according to the following schedule:
- V1 : Inclusion during a preoperative visit
- V2: Surgery
- V3: Follow-up visit at 1 month ± 15 days post-surgery
- V4: Follow-up visit at 6 months ± 30 days post-surgery
- V5: Follow-up visit at 12 months ± 60 days post-surgery
- V6: Follow-up visit at 24 months ± 90 days post-surgery
The following data will be collected:
- Survival rate of implants evaluating the incidence of implants failure, where implant
failure is defined as revision, loosening, or any definite change in the position of
components (V3-V6).
- Clinical and functional outcomes, measured with the International Knee Documentation
Committee (IKDC) score (V1, V3-V6)
- Quality of Life, measured with the EQ-5D score (V1, V3-V6)
- Occurrence of intraoperative and postoperative complications (V2-V6)
Depending on standard practice, imaging assessment of implants and bone tunnels may be
performed.
A web-based data collection tool will be used as Electronic Data Capture (EDC). All the
information required by the protocol will be collected in electronic case report forms
(eCRF).
The statistical analysis will be performed according to a pre-established statistical
analysis plan. Missing values will not be replaced by estimated values but will be considered
as missing in the statistical analysis.
