Anterior Cruciate Ligament InjuryNCT02845141
Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction
A study testing Actifuse and bone graft in people with Anterior Cruciate Ligament Injury, run by Berufsgenossenschaftliche Unfallklinik Ludwigshafen at 1 site in Germany.
Trial summary
The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Actifuse and bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Jul 2017
- 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
- Patients in need of revision anterior cruciate ligament reconstruction
Who cannot join
- Infection, wound healing complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment
The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.
Clinical correlation with the histological and radiological results using the SF36 questionnaire.
Read the detailed description
- Study design: Monocentric, prospective, randomised study. Patients who need revision anterior cruciate ligament reconstruction and show a tunnel enlargement of >10mm will have a first operation filling the tibial/femoral tunnel either with bone graft substitute (Actifuse) or autologous spongiosa.
5 - 6 months after this first operation a CT will be performed to assess the bony consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess vitality of the bone substitute.
An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting.
Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6 months postoperative additional radiological evaluation and clinical assessment using the SF36 questionnaire will be performed.
- Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered by the investigator as a bone graft substitute for tunnel enlargement in patients undergoing revision anterior cruciate ligament reconstruction.
- Duration of Participation: The participation of each subject will be approximately 12 months.
Each subject will undergo revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting. A biopsy will be taken at this operation. A clinical and radiological follow up is planned for further 6 months.
- Subjects: Male and female patients ≥ 18 years. Approximately 40 patients who undergo revision anterior cruciate ligament reconstruction will be included in the study.
Inclusion criteria: Patients in need of revision anterior cruciate ligament reconstruction Exclusion criteria: Infection, wound healing complications
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Actifuse, bone graft
- Keywords
- ACL, Revision surgery, tunnel enlargement, bone substitute material, bone graft
- 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.
ActifuseProcedure or surgery
Also called Baxter Actifuse MIS
bone tunnel filled with Actifuse
bone graftProcedure or surgery
bone graft to fill bone tunnel
| Study group | Role | What they receive |
|---|---|---|
| Actifuse | Experimental | Actifuse to fill bone tunnel Receives: Procedure: Actifuse |
| bone graft | Active comparator | bone graft to fill bone tunnel Receives: Procedure: bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
histological assessment of bony consolidation
histological probes during second intervention to measure bony ingrowth into bone substitute material
Measured: 6 months postop
Secondary outcomes (4)
Tegner Activity Score
functional score
Measured: 3, 6 and 12 Months
IKDC Score
functional score
Measured: 3, 6 and 12 Months
stability measurement using KT1000
functional score
Measured: 3, 6 and 12 Months
SF36-Score
health score
Measured: 3, 6 and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startMar 2013
- Primary completionSep 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berufsgenossenschaftliche Unfallklinik Ludwigshafen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan von Recum, Berufsgenossenschaftliche Unfallklinik Ludwigshafen
- Investigators
- Jan von Recum, MD, Principal investigator, BG Unfallklinik LudwigshafenMarc Schnetzke, MD, Study chair, BG Unfallklinik Ludwigshafen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845141
- Sponsor's protocol ID
- Baxter_Actifuse_001
- Status last verified
- Jan 2018
- First submitted
- 13 Oct 2012
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synthetic Bone Graft Substitute (Actifuse) vs. Autologous Spongiosa for Tunnel Enlargement in Revision Anterior Cruciate Ligament Reconstruction - a Histological and Radiological Assessment
- ClinicalTrials.gov ID
- NCT02845141
- Acronym / sponsor ID
- Baxter_Actifuse_001
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL, Revision surgery, tunnel enlargement, bone substitute material, bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Berufsgenossenschaftliche Unfallklinik LudwigshafenUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- 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.
The overall objective is the histological and radiological assessment of bony consolidation of the tibial/femoral tunnel using either bone graft substitute (Actifuse) or autologous spongiosa in patients undergoing revision anterior cruciate ligament reconstruction.
Clinical correlation with the histological and radiological results using the SF36 questionnaire.
Detailed description
- Study design: Monocentric, prospective, randomised study. Patients who need revision anterior cruciate ligament reconstruction and show a tunnel enlargement of >10mm will have a first operation filling the tibial/femoral tunnel either with bone graft substitute (Actifuse) or autologous spongiosa.
5 - 6 months after this first operation a CT will be performed to assess the bony consolidation of the former tibial/femoral tunnel. An MRI will be performed to assess vitality of the bone substitute.
An osseous biopsy will be taken from the tibial/femoral tunnel at the revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting.
Clinical evaluation will be performed 6 weeks, 3 months and 6 months postoperative. At 6 months postoperative additional radiological evaluation and clinical assessment using the SF36 questionnaire will be performed.
- Treatment: Either autologous spongiosa or Actifuse (MIS applicator) will be administered by the investigator as a bone graft substitute for tunnel enlargement in patients undergoing revision anterior cruciate ligament reconstruction.
- Duration of Participation: The participation of each subject will be approximately 12 months.
Each subject will undergo revision anterior cruciate ligament reconstruction approximately 6 months after bone grafting. A biopsy will be taken at this operation. A clinical and radiological follow up is planned for further 6 months.
- Subjects: Male and female patients ≥ 18 years. Approximately 40 patients who undergo revision anterior cruciate ligament reconstruction will be included in the study.
Inclusion criteria: Patients in need of revision anterior cruciate ligament reconstruction Exclusion criteria: Infection, wound healing complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actifuse | Experimental | Procedure: ActifuseActifuse to fill bone tunnel |
| bone graft | Active comparator | Procedure: bone graftbone graft to fill bone tunnel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients in need of revision anterior cruciate ligament reconstruction
Key exclusion criteria (1 listed)
- Infection, wound healing complications
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 |
|---|---|---|
| ActifuseAlso: Baxter Actifuse MISbone tunnel filled with Actifuse | Procedure or surgery | Actifuse |
| bone graftbone graft to fill bone tunnel | Procedure or surgery | bone graft |
Primary outcome
histological assessment of bony consolidation
Time frame: 6 months postop
histological probes during second intervention to measure bony ingrowth into bone substitute material
4 secondary outcomes
Tegner Activity Score
Time frame: 3, 6 and 12 Months
IKDC Score
Time frame: 3, 6 and 12 Months
stability measurement using KT1000
Time frame: 3, 6 and 12 Months
SF36-Score
Time frame: 3, 6 and 12 Months
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 19 Jan 2018.
- 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.
Jan von Recum, MD principal investigator
BG Unfallklinik Ludwigshafen
Marc Schnetzke, MD study chair
BG Unfallklinik Ludwigshafen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Actifuse and bone graft in people with Anterior Cruciate Ligament Injury, run by Berufsgenossenschaftliche Unfallklinik Ludwigshafen at 1 site in Germany.
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 1 inclusion and 1 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 19 Jan 2018. 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 Germany. 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?
histological assessment of bony consolidation (time frame: 6 months postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2018.