Rupture of the Anterior Cruciate Ligament With Instability of the Knee JointNCT00510848
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament
A study testing autograft tendon and allograft tendon in people with Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
- What is being tested?
- autograft tendon and allograft tendon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2007to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- isolated rupture of the anterior cruciate ligament with instability of the knee joint
- meniscal tear possible to suture
- partial meniscectomies
Who cannot join
- chronic laxity (more than 9 months)
- associated collateral laxity (grade III)
- subtotal or total meniscectomy
- infection or inflammatory disease of the knee joint
- large cartilage lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.
- Being tested
- autograft tendon, allograft tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autograft tendonProcedure or surgery
Reconstruction with an autograft tendon (hamstrings)
allograft tendonProcedure or surgery
Reconstruction with an allograft tendon (tibialis posterior)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reconstruction with an autograft tendon (hamstrings) Receives: Procedure: autograft tendon |
| 2 | Experimental | Reconstruction with an allograft tendon (tibialis posterior) Receives: Procedure: allograft tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray, CT-scan, KT1000
Measured: 12 months
Secondary outcomes (1)
X-rays, CT-scan, KT1000
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2015
- Study completionJul 2015
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 Rupture of the Anterior Cruciate Ligament With Instability of the Knee JointStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Verdonk, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510848
- Sponsor's protocol ID
- 2007/154
- Status last verified
- Dec 2014
- First submitted
- 1 Aug 2007
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Robbrecht C, Claes S, Cromheecke M, Mahieu P, Kakavelakis K, Victor J, Bellemans J, Verdonk P. Reliability of a semi-automated 3D-CT measuring method for tunnel diameters after anterior cruciate ligament reconstruction: A comparison between soft-tissue single-bundle allograft vs. autograft. Knee. 2014 Oct;21(5):926-31. doi: 10.1016/j.knee.2014.05.003. Epub 2014 May 20.
PubMed 25022839
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
- ClinicalTrials.gov ID
- NCT00510848
- Acronym / sponsor ID
- 2007/154
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2007 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 2 Aug 2007 (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.
Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: autograft tendonReconstruction with an autograft tendon (hamstrings) |
| 2 | Experimental | Procedure: allograft tendonReconstruction with an allograft tendon (tibialis posterior) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- isolated rupture of the anterior cruciate ligament with instability of the knee joint
- meniscal tear possible to suture
- partial meniscectomies
Key exclusion criteria (5 listed)
- chronic laxity (more than 9 months)
- associated collateral laxity (grade III)
- subtotal or total meniscectomy
- infection or inflammatory disease of the knee joint
- large cartilage lesion
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 |
|---|---|---|
| autograft tendonReconstruction with an autograft tendon (hamstrings) | Procedure or surgery | 1 |
| allograft tendonReconstruction with an allograft tendon (tibialis posterior) | Procedure or surgery | 2 |
Primary outcome
X-ray, CT-scan, KT1000
Time frame: 12 months
1 secondary outcome
X-rays, CT-scan, KT1000
Time frame: 24 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 2 Dec 2022.
- Derived from this study: PubMed 25022839Robbrecht C, Claes S, Cromheecke M, Mahieu P, Kakavelakis K, Victor J, Bellemans J, Verdonk P. Reliability of a semi-automated 3D-CT measuring method for tunnel diameters after anterior cruciate ligament reconstruction: A comparison between soft-tissue single-bundle allograft vs. autograft. Knee. 2014 Oct;21(5):926-31. doi: 10.1016/j.knee.2014.05.003. Epub 2014 May 20.
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.
Peter Verdonk, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autograft tendon and allograft tendon in people with Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 5 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 2 Dec 2022. 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 Belgium. 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?
X-ray, CT-scan, KT1000 (time frame: 12 months). 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 NCT00510848, 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 2 Dec 2022.