Clinical trial NCT03462823: Use of an Osteoconductive Scaffold in ACL-Reconstruction
Official title: Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL - Anterior Cruciate Ligament Rupture
ACL
ACL Injury
Keywords: ACL Reconstruction
Osteoconductive Scaffold
Bone Tunnel Widening
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized patient-blinded two-group parallel comparison trial using an active comparator.
Primary purpose: TREATMENT

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.

Detailed description: Reconstruction of the anterior cruciate ligament (ACL) using autograft tissue is currently recommended as the standard of care following an ACL tear or rupture, with the bone-tendon-bone (BTB) graft and hamstring tendon graft the most common. Although a BTB autograft is widely recognized to offer high mechanical performance and rapid graft healing, these advantages come at the cost of a longer surgery time and higher risk of severe patient discomfort at the graft harvest site. Use of a hamstring tendon autograft is less painful, but is generally slower to heal with higher risk of mechanical graft failure due to poor bone ingrowth. The aim of the current study is to augment graft-to-bone incorporation by use of an osteoconductive scaffold enlaced into the hamstring tendon autograft. This bovine derived composite bone substitute is inserted into the articular aperture of the femoral bone tunnel and should provide an osteoconductive / osteoinductive environment at a biomimetic attachment site leading to improved secondary graft-fixation and a reduced incidence of tunnel widening.

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.

Secondary objectives aim to assess the clinical outcome of the interventional treatment including patient subjective knee function and objective measures of knee stability.

Eligibility criteria: Inclusion

* 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

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Bone tunnel volume
timeFrame: 0, 4.5, 12 months post surgery
Secondary outcomes:
measure: IKDC Subjective Knee Evaluation Form
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: Lysholm Knee Scoring Scale
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: Tegner Activity Scale
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: KT-1000 Arthrometer Test
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: Lachmann Test
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: Pivot shift test
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
measure: Bone tunnel width
timeFrame: 0 and 42 days, 12 and 24 months post surgery
measure: Osteoconductive scaffold-bone integration
timeFrame: day 0, 4.5 and 12 months post surgery
Other outcomes:
measure: Patient safety
timeFrame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Head of Knee Surgery
name: Sandro Fucentese
role: PRINCIPAL_INVESTIGATOR
References: