Knee Outcome, SubjectiveNCT01033188
Double Bundle Anterior Cruciate Ligament Reconstruction
A study testing Single bundle and Double bundle in people with Knee Outcome, Subjective, run by Oslo University Hospital at 1 site in Norway.
Trial summary
There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Outcome, Subjective
- What is being tested?
- Single bundle and Double bundle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to 20 Jun 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinically verified ACL rupture (history, Lachman test 2+ or more with no endpoint; pos pivot shift and arthroscopically verified) The graft used for AM bundle has a minimum size of 6.0 mm and 5.0 mm for t he PL bundle.
Who cannot join
- PCL injury,
- ACL injury to the contra lateral knee
- > 1+ medial or lateral-posterolateral ligament instability at operation date
- Previous ACL reconstruction
- Meniscal injury leaving < 50% of the meniscus intact
- Established OA as judged by Kellgren 3-4.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Bundle or Double Bundle Anterior Cruciate Ligament Reconstruction. A Randomized, Controlled Trial.
There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one of the most common orthopaedic procedures performed, especially among young, active and healthy individuals. However, reports state that there is a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are unable to regain prior function. Additionally, it has been reported that degenerative joint disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the patients in long term follow up studies.
It is well known that the ACL is composed of 2 functional bundles named after their tibial attachments, the anteromedial (AM) and posterolateral (PL) bundles.
Read more
It is believed that the current single-graft, single-bundle technique for reconstructing the anterior cruciate ligament does not anatomically reconstruct either one of these bundles.
In the last two years, the double bundle technique has been introduced and a few clinical studies are available, however only a few RCTs.
Further study is very important to determine if double-bundle ACL reconstructions should be performed, if single-bundle reconstructions can be adjusted to better adapt to their biomechanical insufficiency in restoring internal rotation torques and valgus moments, and also in trying to identify which patients might better benefit from single-bundle versus double-bundle ACL reconstructions.
Read the detailed description
The aim of this study:
The primary aim is to compare the two operational techniques: single bundle hamstrings versus double bundle hamstrings ACL reconstruction, using the KOOS (Knee Osteoarthritis Outcome Score) Quality of Life(QoL) subscore as the primary outcome and clinical examinations, functional tests and standing radiographs (Kellgren Lawrence method) as secondary outcome measurements. Those assesments will be measured after 1,2 and 5 years after the operation.
Hypothesis:
There are no difference between the two methods as judged by the KOOS QoL subscore.
Questions to be answered:
Is there a difference between double-bundle and single-bundle technique in the subjective outcome scores as measured by the KOOS score? Are there differences between hamstrings single bundle and double bundle technique when the Lachman test and the pivot shift test are being used? Is there a difference between hamstrings double-bundle technique and single-bundle technique in return to sports and activity level? Are there differences between double-bundle technique and single -bundle technique in functional tests (one-leg hop test)? Is there a difference in the development of osteoarthritis between the two techniques?
- Conditions
- Knee Outcome, Subjective
- Being tested
- Single bundle, Double bundle
- Keywords
- double bundle, hamstring graft, ACL reconstruction, single bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single bundleProcedure or surgery
Also called Endobutton
Procedure:
Transarthroscopic technique with medial portal placement of the femoral tunnel. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus. The femoral tunnel is positioned at the anatomic foot print determined by the anatomic landmarks. The graft will be fixed with an Endobutton CL on the femur and with an Biosure PK screw in the tibia with the knee close to extension. Prior to the final fixation, the knee will be taken through flexion and extension movements.The surgery will be carried out by an experienced knee surgeon.
Double bundleProcedure or surgery
Also called Endobutton
Procedure:
Transarthroscopic technique. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus.Through a medial portal 2 tunnels will be anatomically placed in the foot print on the femur and the two tibial tunnels will be placed using the Smith \& Nephew drill guide. The graft will be fixed with 2 Endobuttons on the femur and with 2 Biosure PK screws in the tibia. Prior to the final fixation, the knee will be taken through 20 flexion and extension movements. The PL bundle will be fixed with the knee close to ful extension. The surgery will be carried out by an experienced knee surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Single-bundle technique | Active comparator | Anatomic single-bundle technique Receives: Procedure: Single bundle |
| Double-bundle technique | Active comparator | Anatomic double bundle technique Receives: Procedure: Double bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS score(QOL)
Measured: 1-5 years
Secondary outcomes (1)
Standing radiographs (Kellgren Lawrence methode)
Measured: 3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startJan 2010
- Primary completion20 Jun 2017
- Study completion20 Jun 2017
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 Knee Outcome, SubjectiveStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Engebretsen, Oslo University Hospital
- Investigators
- Lars Engebretsen, Phd, MD, Study chair, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033188
- Sponsor's protocol ID
- 6.2009.234
- Status last verified
- Jul 2023
- First submitted
- 15 Dec 2009
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Aga C, Risberg MA, Fagerland MW, Johansen S, Troan I, Heir S, Engebretsen L. No Difference in the KOOS Quality of Life Subscore Between Anatomic Double-Bundle and Anatomic Single-Bundle Anterior Cruciate Ligament Reconstruction of the Knee: A Prospective Randomized Controlled Trial With 2 Years' Follow-up. Am J Sports Med. 2018 Aug;46(10):2341-2354. doi: 10.1177/0363546518782454. Epub 2018 Jul 18.
PubMed 30021073
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Bundle or Double Bundle Anterior Cruciate Ligament Reconstruction. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01033188
- Acronym / sponsor ID
- 6.2009.234
- Conditions
- Knee Outcome, Subjective
- Keywords
- double bundle, hamstring graft, ACL reconstruction, single bundle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 16 Dec 2009 (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.
There has been an increased awareness towards ACL (anterior cruciate ligament) injuries for Norwegian teams, particularly in handball and soccer. The reported number of reconstructions in Norway ranges from 1500 to 2000 per year, and in the United States from 50,000 to 100,000 per year, making ACL reconstruction one of the most common orthopaedic procedures performed, especially among young, active and healthy individuals. However, reports state that there is a subset of patients (10-40%) who remain subjectively and objectively unstable and/or are unable to regain prior function. Additionally, it has been reported that degenerative joint disease is associated with traditional single-bundle ACL reconstructions in up to 50% of the patients in long term follow up studies.
It is well known that the ACL is composed of 2 functional bundles named after their tibial attachments, the anteromedial (AM) and posterolateral (PL) bundles.
It is believed that the current single-graft, single-bundle technique for reconstructing the anterior cruciate ligament does not anatomically reconstruct either one of these bundles.
In the last two years, the double bundle technique has been introduced and a few clinical studies are available, however only a few RCTs.
Further study is very important to determine if double-bundle ACL reconstructions should be performed, if single-bundle reconstructions can be adjusted to better adapt to their biomechanical insufficiency in restoring internal rotation torques and valgus moments, and also in trying to identify which patients might better benefit from single-bundle versus double-bundle ACL reconstructions.
Detailed description
The aim of this study:
The primary aim is to compare the two operational techniques: single bundle hamstrings versus double bundle hamstrings ACL reconstruction, using the KOOS (Knee Osteoarthritis Outcome Score) Quality of Life(QoL) subscore as the primary outcome and clinical examinations, functional tests and standing radiographs (Kellgren Lawrence method) as secondary outcome measurements. Those assesments will be measured after 1,2 and 5 years after the operation.
Hypothesis:
There are no difference between the two methods as judged by the KOOS QoL subscore.
Questions to be answered:
Is there a difference between double-bundle and single-bundle technique in the subjective outcome scores as measured by the KOOS score? Are there differences between hamstrings single bundle and double bundle technique when the Lachman test and the pivot shift test are being used? Is there a difference between hamstrings double-bundle technique and single-bundle technique in return to sports and activity level? Are there differences between double-bundle technique and single -bundle technique in functional tests (one-leg hop test)? Is there a difference in the development of osteoarthritis between the two techniques?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-bundle technique | Active comparator | Procedure: Single bundleAnatomic single-bundle technique |
| Double-bundle technique | Active comparator | Procedure: Double bundleAnatomic double bundle technique |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Clinically verified ACL rupture (history, Lachman test 2+ or more with no endpoint; pos pivot shift and arthroscopically verified) The graft used for AM bundle has a minimum size of 6.0 mm and 5.0 mm for t he PL bundle.
Key exclusion criteria (6 listed)
- PCL injury,
- ACL injury to the contra lateral knee
- > 1+ medial or lateral-posterolateral ligament instability at operation date
- Previous ACL reconstruction
- Meniscal injury leaving < 50% of the meniscus intact
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 |
|---|---|---|
| Single bundleAlso: EndobuttonProcedure: Transarthroscopic technique with medial portal placement of the femoral tunnel. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus. The femoral tunnel is positioned at the anatomic foot print determined by the anatomic landmarks. The graft will be fixed with an Endobutton CL on the femur and with an Biosure PK screw in the tibia with the knee close to extension. Prior to the final fixation, the knee will be taken through flexion and extension movements.The surgery will be carried out by an experienced knee surgeon. | Procedure or surgery | Single-bundle technique |
| Double bundleAlso: EndobuttonProcedure: Transarthroscopic technique. Harvest of the semitendinosus/gracilis (ST/G) tendons through a 3-5 cm incision at the pes anserinus.Through a medial portal 2 tunnels will be anatomically placed in the foot print on the femur and the two tibial tunnels will be placed using the Smith \& Nephew drill guide. The graft will be fixed with 2 Endobuttons on the femur and with 2 Biosure PK screws in the tibia. Prior to the final fixation, the knee will be taken through 20 flexion and extension movements. The PL bundle will be fixed with the knee close to ful extension. The surgery will be carried out by an experienced knee surgeon. | Procedure or surgery | Double-bundle technique |
Primary outcome
KOOS score(QOL)
Time frame: 1-5 years
1 secondary outcome
Standing radiographs (Kellgren Lawrence methode)
Time frame: 3-5 years
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 27 Jul 2023.
- Derived from this study: PubMed 30021073Aga C, Risberg MA, Fagerland MW, Johansen S, Troan I, Heir S, Engebretsen L. No Difference in the KOOS Quality of Life Subscore Between Anatomic Double-Bundle and Anatomic Single-Bundle Anterior Cruciate Ligament Reconstruction of the Knee: A Prospective Randomized Controlled Trial With 2 Years' Follow-up. Am J Sports Med. 2018 Aug;46(10):2341-2354. doi: 10.1177/0363546518782454. Epub 2018 Jul 18.
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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.
Lars Engebretsen, Phd, MD study chair
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single bundle and Double bundle in people with Knee Outcome, Subjective, run by Oslo University Hospital at 1 site in Norway.
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 6 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 27 Jul 2023. 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 Norway. 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?
KOOS score(QOL) (time frame: 1-5 years). 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 NCT01033188, 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 27 Jul 2023.