ACL InjuryNCT06001164
Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction
A study testing ACL reconstruction: Double bundle and ACL reconstruction: Single bundle in people with ACL Injury, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACL Injury
- What is being tested?
- ACL reconstruction: Double bundle and ACL reconstruction: Single bundle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteFinland
- Study dates
- 6 Apr 2021to 30 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results
The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.
- Conditions
- ACL Injury
- Being tested
- ACL reconstruction: Double bundle, ACL reconstruction: Single bundle
- 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.
ACL reconstruction: Double bundleProcedure or surgery
DB: Two tunnels were created on the femoral side through an anteromedial portal. These tunnels were created manually. On the tibial side, the tunnels were created using a guide to ensure they matched the anatomic insertion site of the ACL at the tibia. The hamstring grafts for the procedure were then harvested from the same leg and doubled. The femoral side was fixed from the inside out, whereas the tibial side was fixed from the outside in. bioresorbable screws were used.
ACL reconstruction: Single bundleProcedure or surgery
SB: The femoral tunnel was created using an anteromedial portal. A freehand technique was used. For the tibial tunnel, a tibial guide was used to ensure it was positioned at the midpoint of the tibial ACL attachment site. The tendons of the semitendinosus and gracilis muscles were then harvested, doubled over, and inserted through the tibial tunnel, extending into the femur, and fixed with metallic or bioabsorbable interference screws.
| Study group | Role | What they receive |
|---|---|---|
| Double-bundle | Active comparator | Not described Receives: Procedure: ACL reconstruction: Double bundle |
| Single-bundle | Active comparator | Not described Receives: Procedure: ACL reconstruction: Single bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
osteoarthritis (OA)
which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Measured: 15 years
Pivot shift
which group has more positive pivot shift tests? Always compared to a "healthy" knee.
Measured: 15 years
KT-1000 arthrometer difference
Anteroposterior translation. Always compared to a "healthy" knee. mm.
Measured: 15 years
Lysholm score
subjective evaluation form. Scale 0-100 (100=best)
Measured: 15 years
IKDC subjective evaluation. Scale 0-100 (100=best)
subjective evaluation form
Measured: 15 years
IKDC objective score. Scale 1-4 (1=best)
Overall evaluation of the knee
Measured: 15 years
graft failures
which group has more graft failures? The number of graft failures was assessed by revision surgery.
Measured: 15 years
Range on motion (ROM) of the knee
Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral "healthy" knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal < 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal > 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal > 25°).
Measured: 15 years
One leg hop test
One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start6 Apr 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arttu Seppanen, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001164
- Sponsor's protocol ID
- R20001
- Status last verified
- Aug 2023
- First submitted
- 11 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 15-Year Results
- ClinicalTrials.gov ID
- NCT06001164
- Acronym / sponsor ID
- R20001
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Aug 2023 (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.
The purpose of this study is to compare double-bundle and single-bundle techniques for ACL reconstruction in a long-term 15-year follow-up. Our hypothesis is that the DB technique is better than the SB technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-bundle | Active comparator | Procedure: ACL reconstruction: Double bundle |
| Single-bundle | Active comparator | Procedure: ACL reconstruction: Single bundle |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- To be eligible for the study, patients had to meet certain criteria, including primary ACL reconstruction, closed growth plates, and no ligamentous injuries to the contralateral knee.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ACL reconstruction: Double bundleDB: Two tunnels were created on the femoral side through an anteromedial portal. These tunnels were created manually. On the tibial side, the tunnels were created using a guide to ensure they matched the anatomic insertion site of the ACL at the tibia. The hamstring grafts for the procedure were then harvested from the same leg and doubled. The femoral side was fixed from the inside out, whereas the tibial side was fixed from the outside in. bioresorbable screws were used. | Procedure or surgery | Double-bundle |
| ACL reconstruction: Single bundleSB: The femoral tunnel was created using an anteromedial portal. A freehand technique was used. For the tibial tunnel, a tibial guide was used to ensure it was positioned at the midpoint of the tibial ACL attachment site. The tendons of the semitendinosus and gracilis muscles were then harvested, doubled over, and inserted through the tibial tunnel, extending into the femur, and fixed with metallic or bioabsorbable interference screws. | Procedure or surgery | Single-bundle |
Primary outcome
osteoarthritis (OA)
Time frame: 15 years
which group has more osteoarthritis? Kellgren Lawrence classification. Scale 0-4 (0=no OA)
Pivot shift
Time frame: 15 years
which group has more positive pivot shift tests? Always compared to a "healthy" knee.
KT-1000 arthrometer difference
Time frame: 15 years
Anteroposterior translation. Always compared to a "healthy" knee. mm.
Lysholm score
Time frame: 15 years
subjective evaluation form. Scale 0-100 (100=best)
IKDC subjective evaluation. Scale 0-100 (100=best)
Time frame: 15 years
subjective evaluation form
IKDC objective score. Scale 1-4 (1=best)
Time frame: 15 years
Overall evaluation of the knee
graft failures
Time frame: 15 years
which group has more graft failures? The number of graft failures was assessed by revision surgery.
Range on motion (ROM) of the knee
Time frame: 15 years
Which group has more lack of knee extension or lack of knee flexion? Injured knee is always compared to a contralateral "healthy" knee. Measurements were performed with a goniometer. ROM included lack of passive extension (normal < 3°, nearly normal 3-5°, abnormal 6-10°, and severely abnormal > 10°) and lack of passive flexion (normal 0-5°, nearly normal 6-15°, abnormal 16-25°, and severely abnormal > 25°).
One leg hop test
Time frame: 15 years
One leg hop test was performed to assess the functional capacity of the knee. The patient hopped a maximum length three times on each leg separately and the best result was recorded for both legs. The result of the operated leg was then compared with that of the non-operated leg.
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 21 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction: Double bundle and ACL reconstruction: Single bundle in people with ACL Injury, run by Tampere University Hospital at 1 site in Finland.
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 21 Aug 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 Finland. 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?
osteoarthritis (OA) (time frame: 15 years). The study lists 9 primary outcomes in all. 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 21 Aug 2023; AzTrials last refreshed its copy on 1 Nov 2026.