Treatment of the anterior cruciate ligament rupture with a magnesium-based interference screw: a single group multicenter trial

Treatment of the anterior cruciate ligament rupture with a magnesium-based interference screw: a single group multicenter trial - CROMAG

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022060

Enrollment

Registered

2020-06-29

Start date

2021-08-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of the anterior cruciate ligament (ACL)

Interventions

Group 1: Replacement of the anterior cruciate ligament with the semitendinosus tendon in case of a new anterior cruciate ligament rupture. The tendon is fixated with a MAGNEZIX® IFSc interference scre

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Anterior cruciate ligament rupture leading to an at least 5mm side-to-side difference of antero-posterior translation in the Lachman Test of the knee, using a KT-1000. 2. Age =18 years. 3. Written informed consent for trial.

Exclusion criteria

Exclusion criteria: 1. Multi ligament injury, such as concomitant collateral ligament and/or the posterior cruciate ligament injuries. 2. History of ligament injuries of the contralateral knee. 3. Primary or secondary osteoporosis. 4. Existing degeneration of the meniscus. 5. Degenerative cartilage damage in the sense of an emerging or manifest arthrosis which is latestly diagnosed intraoperatively during the arthroscopic staging. 6. Pregnancy, suspected pregnancy or breastfeeding period.

Design outcomes

Primary

Measure	Time frame
Knee injury and Osteoarthritis Outcome Score (KOOS4) in its German version 12 months post-surgery (compared to pre-surgery)	—

Secondary

Measure	Time frame
• Safety: adverse device effect during surgery or wound healing, revision during 1 year, serious adverse device effect during 1 year, no full resilience of the knee after 3 months • Lachman test: Anterior-posterior laxity measured as side-to-side difference (in mm) with the KT-1000 arthrometer using 35 pounds postoperatively at 1 year compared to pre-operatively • Rotational stability after 12 and 24 months • Knee function and muscle circumference after 12 and 24 months • Duration of inability to work • EuroQol (EQ-5D-5L) at time of study inclusion and at 3, 6, 12 and 24 months • Tegner Activity Scale after 12 and 24 months • Modified Lysholm Knee Score after 12 and 24 months • KOOS4 after 24 months • KOOS5 after 12 and 24 months • Each dimension of the KOOS after 12 and 24 months • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score after 12 and 24 months • IKDC Objective Score after 12 and 24 months Assessment of safety: Possible complications include infection, delayed wound healing, vascular events, screw-related complications, revision surgery.	—

Measure

Time frame

• Safety: adverse device effect during surgery or wound healing, revision during 1 year, serious adverse device effect during 1 year, no full resilience of the knee after 3 months • Lachman test: Anterior-posterior laxity measured as side-to-side difference (in mm) with the KT-1000 arthrometer using 35 pounds postoperatively at 1 year compared to pre-operatively • Rotational stability after 12 and 24 months • Knee function and muscle circumference after 12 and 24 months • Duration of inability to work • EuroQol (EQ-5D-5L) at time of study inclusion and at 3, 6, 12 and 24 months • Tegner Activity Scale after 12 and 24 months • Modified Lysholm Knee Score after 12 and 24 months • KOOS4 after 24 months • KOOS5 after 12 and 24 months • Each dimension of the KOOS after 12 and 24 months • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score after 12 and 24 months • IKDC Objective Score after 12 and 24 months Assessment of safety: Possible complications include infection, delayed wound healing, vascular events, screw-related complications, revision surgery.

—

Countries

Germany

Contacts

Public ContactMax Kolvenbach

Syntellix AG

info@syntellix.com+49 511 27041350

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026