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Use of an Osteoconductive Scaffold in ACL-Reconstruction

NCT03462823 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-08-06

No results posted yet for this study

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.

Conditions

  • ACL - Anterior Cruciate Ligament Rupture
  • ACL
  • ACL Injury

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.

Sponsors & Collaborators

  • Sandro Fucentese

    lead OTHER

Principal Investigators

  • Sandro Fucentese · Head of Knee Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-29
Primary Completion
2024-01-29
Completion
2025-12-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03462823 on ClinicalTrials.gov