ACL - Anterior Cruciate Ligament RuptureACLROCSNCT03462823
Use of an Osteoconductive Scaffold in ACL-Reconstruction
A study testing Osteoconductive scaffold-hamstring tendon composite repair and Hamstring tendon-only repair in people with ACL - Anterior Cruciate Ligament Rupture and ACL, run by Sandro Fucentese at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture, ACL, ACL Injury
- What is being tested?
- Osteoconductive scaffold-hamstring tendon composite repair and Hamstring tendon-only repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2017to 11 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
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.
Read the 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.
- Conditions
- ACL - Anterior Cruciate Ligament Rupture, ACL, ACL Injury
- Being tested
- Osteoconductive scaffold-hamstring tendon composite repair, Hamstring tendon-only repair
- Keywords
- ACL Reconstruction, Osteoconductive Scaffold, Bone Tunnel Widening
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteoconductive scaffold-hamstring tendon composite repairDevice
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).
Hamstring tendon-only repairDevice
ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Control treatment | Active comparator | ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care. Receives: Device: Hamstring tendon-only repair |
| Experimental treatment | Experimental | ACL-reconstruction using hamstring autograft with hybrid fixation combined with the osteoconductive device under study. Receives: Device: Osteoconductive scaffold-hamstring tendon composite repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone tunnel volume
CT based relative change of the femoral bone tunnel volume from baseline to follow-up 1 and 2.
Measured: 0, 4.5, 12 months post surgery
Secondary outcomes (8)
IKDC Subjective Knee Evaluation Form
International Knee Documentation Committee Subjective Knee Evaluation Form is designed to detect improvement or deterioration in symptoms, function and sports activities due to knee impairment for patients with a variety of knee conditions including ligament injuries. It is a patient-completed questionnaire available in multiple languages including German with an ordinal scoring system ranging from 0 (highest level of symptoms or lowest level of function) to 100 (no limitation with daily or sporting activities and the absence of symptoms).
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Lysholm Knee Scoring Scale
To evaluate outcomes of knee ligament surgery, particularly symptoms of instability. It has an ordinal scoring system ranging from 0 to 100 (No symptoms or disability). A validated German version will be used.
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Tegner Activity Scale
The Tegner activity scale (TAS) is used to measure the change in physical activity from pre-injury to follow-up. Patient's activity is scored on a scale with 11 levels from level 0 (on sick leave/disability) to level 10 (participation in competitive sports such as soccer at a national or international elite level). Evaluated will be the difference in score from pre-injury (assessed at baseline visit) to follow-up.
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
KT-1000 Arthrometer Test
The KT-1000 Arthrometer Test measures anterior displacement of the tibial plateau on the femur at a specific force. Its output variable is defined as the difference in full millimeters between the tibial displacement of the ACL reconstructed knee and the normal contralateral side.
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Lachmann Test
The Lachman test measures anterior displacement conducted manually by the clinician. It is graded as the difference from the normal contralateral side as 0 (<3 mm), 1 (3 to 5 mm), or 2 (>5 mm).
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Pivot shift test
The pivot shift test assesses the combined tibio-femoral rotation and anterior tibial translation. The pathologic motion elicited is graded as a glide (grade 1), clunk (grade 2), or gross clunk with locking (grade 3). A normal finding is graded as zero. The outcome measure is calculated from the difference between affected (repaired) and intact knee.
Measured: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Bone tunnel width
Bone tunnel width will additionally be assessed on plain radiograph. Standard posteroanterior radiographs of the knee in full extension will be used. Bone tunnel width will be assessed at the widest part of the femoral bone tunnel. Assessed will be the relative change in femoral bone tunnel width.
Measured: 0 and 42 days, 12 and 24 months post surgery
Osteoconductive scaffold-bone integration
For a quantitative analysis of Osteoconductive scaffold (OCS)-bone integration, the mineral density profile along a predefined line will be examined. A slice showing the central portion of the OCS in the axial plane will be selected. A straight line of 2 cm length will be drawn perpendicular to the long axis of the OCS using image analysis software (Mimics). The CT-values along this line will be recorded and evaluated in the following way. Since the CT-values change according to the bone mineral density, the profile along the line will have a minimum at the interface of the tunnel wall and the OCS and a maximum on the OCS. The difference in Hounsfield units from the cancellous bone in the tunnel wall and the OCS-bone interface will be used as a measure for the degree of osseous integration of the implant.
Measured: day 0, 4.5 and 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start29 Apr 2017
- Primary completion29 Jan 2024
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized patient-blinded two-group parallel comparison trial using an active comparator.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandro Fucentese
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandro Fucentese, Balgrist University Hospital
- Investigators
- Sandro Fucentese, Principal investigator, Head of Knee Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462823
- Sponsor's protocol ID
- W652
- Acronym
- ACLROCS
- Status last verified
- Jul 2026
- First submitted
- 29 Dec 2017
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37347015
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for the Use of an Osteoconductive Scaffold in ACL-Reconstruction
- ClinicalTrials.gov ID
- NCT03462823
- Acronym / sponsor ID
- ACLROCS / W652
- Conditions
- ACL - Anterior Cruciate Ligament Rupture, ACL, ACL Injury
- Keywords
- ACL Reconstruction, Osteoconductive Scaffold, Bone Tunnel Widening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sandro FucenteseUniversity, hospital or other
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized patient-blinded two-group parallel comparison trial using an active comparator.
| Arm | Type | Receives |
|---|---|---|
| Control treatment | Active comparator | Device: Hamstring tendon-only repairACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care. |
| Experimental treatment | Experimental | Device: Osteoconductive scaffold-hamstring tendon composite repairACL-reconstruction using hamstring autograft with hybrid fixation combined with the osteoconductive device under study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteoconductive scaffold-hamstring tendon composite repairThe 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 | Experimental treatment |
| Hamstring tendon-only repairACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care. | Device | Control treatment |
Primary outcome
Bone tunnel volume
Time frame: 0, 4.5, 12 months post surgery
CT based relative change of the femoral bone tunnel volume from baseline to follow-up 1 and 2.
8 secondary outcomes
IKDC Subjective Knee Evaluation Form
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Lysholm Knee Scoring Scale
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Tegner Activity Scale
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
KT-1000 Arthrometer Test
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Lachmann Test
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Pivot shift test
Time frame: 0 and 42 days, 6 months, 1, 2 and 5 years post surgery
Bone tunnel width
Time frame: 0 and 42 days, 12 and 24 months post surgery
Osteoconductive scaffold-bone integration
Time frame: day 0, 4.5 and 12 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 37347015Gotschi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandro Fucentese principal investigator
Head of Knee Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteoconductive scaffold-hamstring tendon composite repair and Hamstring tendon-only repair in people with ACL - Anterior Cruciate Ligament Rupture and ACL, run by Sandro Fucentese at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone tunnel volume (time frame: 0, 4.5, 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462823, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.