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A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeriACL Device ACL Reconstruction | Device | Long-term Bioresorbable ACL Scaffold |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Adverse Events | 12 months | |
| KT-1000 Arthrometer Knee Laxity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Surveys | 12 months |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Paessler, MD | ATOS Clinic, Heidelberg | Principal Investigator |
| Johan Bellemans, MD | UZ Leuven, Belgium | Principal Investigator |
| Holger Schmitt, MD | Heidelberg University | Principal Investigator |
| Gerhard Oberthaler, MD | Dr. Pierer Sanatorium, Salzburg, Austria | Principal Investigator |
| Uwe Pietzner, MD | Dietrich-Bonhöffer-Klinik, Altentreptow, Germany | Principal Investigator |
| Michael Jagodzsinki, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Pierer Sanatorium | Salzburg | Austria | ||||
| UZ Leuven |
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| Leuven |
| Belgium |
| Dietrich-Bonhöffer-Klinik | Altentreptow | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| ATOS Clinic | Heidelberg | Germany |
| University of Heidelberg | Heidelberg | Germany |