Use of an Osteoconductive Scaffold in ACL-Reconstruction

NCT03462823 | Active Not Recruiting DMC

• 1 other identifier: W652
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ACL Reconstruction; Osteoconductive Scaffold; Bone Tunnel Widening

Outcome Measures

Primary Outcomes (1)

• Bone tunnel volume

  CT based relative change of the femoral bone tunnel volume from baseline to follow-up 1 and 2.

  0, 4.5, 12 months post surgery

Secondary Outcomes (8)

• IKDC Subjective Knee Evaluation Form

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

• Lysholm Knee Scoring Scale

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

• Tegner Activity Scale

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

• KT-1000 Arthrometer Test

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

• Lachmann Test

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

Other Outcomes (1)

• Patient safety

  0 and 42 days, 6 months, 1, 2 and 5 years post surgery

Study Arms (2)

Control treatment

ACTIVE COMPARATOR

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

Device: Hamstring tendon-only repair

Experimental treatment

EXPERIMENTAL

ACL-reconstruction using hamstring autograft with hybrid fixation combined with the osteoconductive device under study.

Device: Osteoconductive scaffold-hamstring tendon composite repair

Interventions

Osteoconductive scaffold-hamstring tendon composite repair DEVICE

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).

Experimental treatment

Hamstring tendon-only repair DEVICE

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

Control treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Acute unilateral complete tear of the ACL that occurred within 18 weeks before planned surgery and requires reconstruction of the
• Informed consent as documented by signature

You may not qualify if:

• Prior ACL reconstruction or other surgical procedure on the affected knee.
• Prior fracture of the affected leg.
• Multi-ligament reconstruction.
• Previous or current ACL injury on contra-lateral leg.
• Medical condition or comorbidity that would interfere with study participation.
• The patient is mentally compromised.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Other clinically significant concomitant disease states (e.g. renal failure, hepatic dysfunction, cardiovascular disease, etc.).

Sponsors & Collaborators

• Sandro Fucentese: lead

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Related Publications (1)

• Gotschi T, Hodel S, Kuhne N, Bachmann E, Li X, Zimmermann SM, Snedeker JG, Fucentese SF. Osteoconductive Scaffold Placed at the Femoral Tunnel Aperture in Hamstring Tendon ACL Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2023 Jun 5;11(6):23259671231174478. doi: 10.1177/23259671231174478. eCollection 2023 Jun.

  PMID: 37347015 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Sandro Fucentese

  Head of Knee Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Knee Surgery

Model Details: Randomized patient-blinded two-group parallel comparison trial using an active comparator.

Study Record Dates

• First Submitted: December 29, 2017
• First Posted: March 13, 2018
• Study Start: April 29, 2017
• Primary Completion: January 29, 2024
• Study Completion: December 29, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)