The Biocomposite properties of a poly96L/4D copolymer-bTCP interference screw at five years post-operative: A Pilot Study

The Biocomposite properties of a poly96L/4D copolymer-bTCP interference screw at five years post-operative: A Pilot Study - long-term properties of an ACL reconstruction screw / MATRYX

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40945

Enrollment

Registered

2014-05-19

Start date

2014-12-23

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

long-term absorption rate of the screw

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - graft fixation with a Matryx interference screw - Age 18-50 years at time of surgery - Male - Primary ACL reconstruction with a single bundle ST or STG autograft - Minimum 5years postoperative

Exclusion criteria

Exclusion criteria: - Subsequent surgery on the affected limb after the index ACL surgery - Failed ACL reconstruction: defined as meeting at least one of the following: Lachman*s of 1+ or greater Positive pivot shift IKDC C and D - Any condition that would exclude a patient from undergoing a CT scan - Concomitant ligament or bone pathology at the time of index procedure or subsequently - Double bundle/tunnel - Smoker - Diabetic - Auto-immune conditions - Elite Athletes - Metastatic bone disease - Female (note: excluded due to pregnancy possibility)

Design outcomes

Primary

Measure	Time frame
Primary study parameters / outcome of the study • Standardized CT scan at a minimum of five years post-operative. • Absorption using Housfield unit density (HU) • Osteoconduction using Barber & Dockery Ossification Quality Score • Biocompatibility	—

Secondary

Measure	Time frame
Secondary study parameters / outcome of the study (if applicable) 1. Clinical exam tests and measures (i.e. ROM, Lachmans, Drawer, pivot shift test, etc.) 2. Functional tests (1 leg hop; jump; squat; etc.) 3. Patient satisfaction outcomes: • Disease-specific: ACL-QOL • Joint specific: IKDC • General Health: SF-36 • Activy Score: Tegner 4. Intra-operative: • Procedureal details (tunnel length, diameter, etc.) • Adverse events	—

Measure

Time frame

Secondary study parameters / outcome of the study (if applicable) 1. Clinical exam tests and measures (i.e. ROM, Lachmans, Drawer, pivot shift test, etc.) 2. Functional tests (1 leg hop; jump; squat; etc.) 3. Patient satisfaction outcomes: • Disease-specific: ACL-QOL • Joint specific: IKDC • General Health: SF-36 • Activy Score: Tegner 4. Intra-operative: • Procedureal details (tunnel length, diameter, etc.) • Adverse events

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Countries

Netherlands

Outcome results