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ACTIVE NOT RECRUITING
NCT03462823
NA

Use of an Osteoconductive Scaffold in ACL-Reconstruction

Sponsor: Sandro Fucentese

View on ClinicalTrials.gov

Summary

Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.

Official title: Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2017-04-29

Completion Date

2025-12-29

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

DEVICE

Osteoconductive scaffold-hamstring tendon composite repair

The device under study is a composite bone substitute composed of a natural mineral matrix of bovine origin, reinforced with biodegradable synthetic polymers and natural collagen derivatives of bovine origin (smartbone, IBI S.A., Switzerland).

DEVICE

Hamstring tendon-only repair

ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.

Locations (1)

Balgrist University Hospital

Zurich, Switzerland