Anterior Cruciate Ligament ReconstructionNCT06303726
Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction
A study testing ACL reconstruction single bundle and ACL reconstruction double bundle in people with Anterior Cruciate Ligament Reconstruction, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- ACL reconstruction single bundle and ACL reconstruction double bundle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 25 Apr 2022to 25 Jun 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- complete ACL rupture
- symptoms and clinical sings for rupture of ACL (instability of knee, swelling, pain, reduced knee function,...)
- patient consent
- magnetic resonance with this of kind injury
Who cannot join
- associated injuries to other knee ligaments
- major meniscus injuries
- X-ray abnormalities of injured knee
- preliminary ACL reconstruction
- associated injury to the other knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction: Short-term and Long-term Function and Imaging Results
The goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).
The main question it aims to answer are:
Read more
- which surgery gives better outcome in patients (short- and long-term results)?
- are there any sings of osteoarthritis in an injured knee compared to a healthy knee?
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery.
Read the detailed description
Double bundle (DB) ACL reconstruction has gained popularity in the last few years. Biomechanical and intra - operative studies have shown better antero - posterior and rotational stability after DB vs. single bundle (SB) reconstruction. However, only few studies are found in the literature that have evaluated and compared clinical results between SB and DB ACL reconstruction. All reported studies used hamstrings in both DB and SB techniques. No studies were found that used patellar tendon autograft for the SB.
The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques.
A total of 40 patients (29 male and 11 female, average (SD) age 36) were randomized during routine surgery (2 years after the surgery) into either double bundle (DB) or single bundle (SB) group. Patients with combined (medial, lateral or posterior) ligamentous injuries were not included in the study. ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation. In the SB group patellar tendon autograft was fixed with titanium interference screws. The same postoperative rehabilitation protocols were used for both groups.
Subjective evaluation comprised IKDC (International Knee Documentation Committee) subjective score, Tegner activity and Lysholm scores. Objective evaluation was done by the IKDC 2000 knee examination protocol. Antero - posterior stability was measured by KT 2000 (knee arthrometer) and by Rollimeter. One leg hop test was performed to assess the functional results. Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed.
The same protocol was performed for the clinical exams after 15 years since surgery. A total of 30 patients were examen. Investigators also did imaging of both knees (X-ray and MRI) for checking the sings of osteoarthritis.
- Being tested
- ACL reconstruction single bundle, ACL reconstruction double bundle
- Keywords
- anterior cruciate ligament, bone to bone (BTB), single bundle, double bundle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction single bundleProcedure or surgery
We will do surgery of ACL reconstruction with patellar ligament.
ACL reconstruction double bundleProcedure or surgery
We will do surgery of ACL reconstruction with hamstring ligament.
| Study group | Role | What they receive |
|---|---|---|
| Single bundle ACL reconstruction | Active comparator | In this group we chose to do surgery of ACL reconstruction with single bundle (patellar ligament). Receives: Procedure: ACL reconstruction single bundle |
| Double bundle ACL reconstruction | Active comparator | In this group we chose to do surgery of ACL reconstruction with double bundle - hamstring ligament. Receives: Procedure: ACL reconstruction double bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
IKDC SUBJECTIVE SCORE
Daily activities, limitations
Measured: before surgery, 2 years and 15 years after surgery
TEGNER SCORE
Daily activities, limitations
Measured: 2 years and 15 years after surgery
LYSHOLM SCORE
Daily activities, limitations
Measured: 2 years and 15 years after surgery
OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS
Measurements with Biodex isokinetic Dynamometer (deficit (%) at 60 deg/s and 180 deg/s; operated to nonoperated ratio (total work))
Measured: 2 years and 15 years after surgery
OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior)
Measured by KT 1000 and Rollimeter. Laxity was expressed as the difference between injured knee and uninjured knee in millimeters.
Measured: 2 years and 15 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start25 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies 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
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitja Kozic, Study chair, University Clinical Center Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303726
- Sponsor's protocol ID
- IRP-2021/02-19
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Fo now we are not planning to share any participant data to other researchers.
Publications
Maynard MJ, Deng X, Wickiewicz TL, Warren RF. The popliteofibular ligament. Rediscovery of a key element in posterolateral stability. Am J Sports Med. 1996 May-Jun;24(3):311-6. doi: 10.1177/036354659602400311.
PubMed 8734881Freeman MA, Pinskerova V. The movement of the knee studied by magnetic resonance imaging. Clin Orthop Relat Res. 2003 May;(410):35-43. doi: 10.1097/01.blo.0000063598.67412.0d.
PubMed 12771815Browne C, Hermida JC, Bergula A, Colwell CW Jr, D'Lima DD. Patellofemoral forces after total knee arthroplasty: effect of extensor moment arm. Knee. 2005 Apr;12(2):81-8. doi: 10.1016/j.knee.2004.05.006.
PubMed 15749440Nuno N, Ahmed AM. Sagittal profile of the femoral condyles and its application to femorotibial contact analysis. J Biomech Eng. 2001 Feb;123(1):18-26. doi: 10.1115/1.1339819.
PubMed 11277297Siu D, Rudan J, Wevers HW, Griffiths P. Femoral articular shape and geometry. A three-dimensional computerized analysis of the knee. J Arthroplasty. 1996 Feb;11(2):166-73. doi: 10.1016/s0883-5403(05)80012-9.
PubMed 8648311Lonner JH, Jasko JG, Thomas BS. Anthropomorphic differences between the distal femora of men and women. Clin Orthop Relat Res. 2008 Nov;466(11):2724-9. doi: 10.1007/s11999-008-0415-0. Epub 2008 Aug 22.
PubMed 18719975Griffin FM, Insall JN, Scuderi GR. The posterior condylar angle in osteoarthritic knees. J Arthroplasty. 1998 Oct;13(7):812-5. doi: 10.1016/s0883-5403(98)90036-5.
PubMed 9802670Yoon KH, Kim JS, Kim SJ, Park M, Park SY, Park SE. Eight-year results of transtibial nonanatomic single-bundle versus double-bundle anterior cruciate ligament reconstruction: Clinical, radiologic outcomes and survivorship. J Orthop Surg (Hong Kong). 2019 May-Aug;27(2):2309499019840827. doi: 10.1177/2309499019840827.
PubMed 30955412Freedman KB, D'Amato MJ, Nedeff DD, Kaz A, Bach BR Jr. Arthroscopic anterior cruciate ligament reconstruction: a metaanalysis comparing patellar tendon and hamstring tendon autografts. Am J Sports Med. 2003 Jan-Feb;31(1):2-11. doi: 10.1177/03635465030310011501.
PubMed 12531750Adravanti P, Dini F, de Girolamo L, Cattani M, Rosa MA. Single-Bundle versus Double-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial with 6-Year Follow-up. J Knee Surg. 2017 Nov;30(9):898-904. doi: 10.1055/s-0037-1598176. Epub 2017 Feb 20.
PubMed 28219088Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
PubMed 8536037Shaieb MD, Kan DM, Chang SK, Marumoto JM, Richardson AB. A prospective randomized comparison of patellar tendon versus semitendinosus and gracilis tendon autografts for anterior cruciate ligament reconstruction. Am J Sports Med. 2002 Mar-Apr;30(2):214-20. doi: 10.1177/03635465020300021201.
PubMed 11912091Jarvela S, Kiekara T, Suomalainen P, Jarvela T. Double-Bundle Versus Single-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Study With 10-Year Results. Am J Sports Med. 2017 Sep;45(11):2578-2585. doi: 10.1177/0363546517712231. Epub 2017 Jun 29.
PubMed 28661696Briggs KK, Steadman JR, Hay CJ, Hines SL. Lysholm score and Tegner activity level in individuals with normal knees. Am J Sports Med. 2009 May;37(5):898-901. doi: 10.1177/0363546508330149. Epub 2009 Mar 23.
PubMed 19307332Marmura H, Getgood AMJ, Spindler KP, Kattan MW, Briskin I, Bryant DM. Validation of a Risk Calculator to Personalize Graft Choice and Reduce Rupture Rates for Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Jun;49(7):1777-1785. doi: 10.1177/03635465211010798. Epub 2021 May 4.
PubMed 33945339
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-bundle Versus Double-bundle Anterior Cruciate Ligament Reconstruction: Short-term and Long-term Function and Imaging Results
- ClinicalTrials.gov ID
- NCT06303726
- Acronym / sponsor ID
- IRP-2021/02-19
- Keywords
- anterior cruciate ligament, bone to bone (BTB), single bundle, double bundle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 12 Mar 2024 (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 goal of this retrospective randomized study is to compare two surgical techniques (single vs. double bundle) of ACL (anterior cruciate ligament) reconstructions in participants with rupture of anterior cruciate ligament without major other injuries of the injured knee (exclusion criteria defined).
The main question it aims to answer are:
- which surgery gives better outcome in patients (short- and long-term results)?
- are there any sings of osteoarthritis in an injured knee compared to a healthy knee?
Participants will be invited to our clinic after 15 years to do clinical and functional exams with x-Ray and magnetic resonance imaging (MRI) of both knees. Subjective exams with different scores (Tegner score, Lysholm score..) were also done. The same exam protocol for participant was used again after two years and fifteen years since surgery.
Detailed description
Double bundle (DB) ACL reconstruction has gained popularity in the last few years. Biomechanical and intra - operative studies have shown better antero - posterior and rotational stability after DB vs. single bundle (SB) reconstruction. However, only few studies are found in the literature that have evaluated and compared clinical results between SB and DB ACL reconstruction. All reported studies used hamstrings in both DB and SB techniques. No studies were found that used patellar tendon autograft for the SB.
The purpose of the present study was therefore to evaluate and compare the clinical results of DB hamstring and SB patellar tendon ACL reconstruction techniques.
A total of 40 patients (29 male and 11 female, average (SD) age 36) were randomized during routine surgery (2 years after the surgery) into either double bundle (DB) or single bundle (SB) group. Patients with combined (medial, lateral or posterior) ligamentous injuries were not included in the study. ACL reconstruction in DB group was done by four tunnel hamstring technique with EndoButton femoral and cancellous screw tibial fixation. In the SB group patellar tendon autograft was fixed with titanium interference screws. The same postoperative rehabilitation protocols were used for both groups.
Subjective evaluation comprised IKDC (International Knee Documentation Committee) subjective score, Tegner activity and Lysholm scores. Objective evaluation was done by the IKDC 2000 knee examination protocol. Antero - posterior stability was measured by KT 2000 (knee arthrometer) and by Rollimeter. One leg hop test was performed to assess the functional results. Isokinetic thigh muscle strength measurements on Biodex isokinetic dynamometer were performed.
The same protocol was performed for the clinical exams after 15 years since surgery. A total of 30 patients were examen. Investigators also did imaging of both knees (X-ray and MRI) for checking the sings of osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single bundle ACL reconstruction | Active comparator | Procedure: ACL reconstruction single bundleIn this group we chose to do surgery of ACL reconstruction with single bundle (patellar ligament). |
| Double bundle ACL reconstruction | Active comparator | Procedure: ACL reconstruction double bundleIn this group we chose to do surgery of ACL reconstruction with double bundle - hamstring ligament. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- complete ACL rupture
- symptoms and clinical sings for rupture of ACL (instability of knee, swelling, pain, reduced knee function,...)
- patient consent
- magnetic resonance with this of kind injury
Key exclusion criteria (5 listed)
- associated injuries to other knee ligaments
- major meniscus injuries
- X-ray abnormalities of injured knee
- preliminary ACL reconstruction
- associated injury to the other knee
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 single bundleWe will do surgery of ACL reconstruction with patellar ligament. | Procedure or surgery | Single bundle ACL reconstruction |
| ACL reconstruction double bundleWe will do surgery of ACL reconstruction with hamstring ligament. | Procedure or surgery | Double bundle ACL reconstruction |
Primary outcome
IKDC SUBJECTIVE SCORE
Time frame: before surgery, 2 years and 15 years after surgery
Daily activities, limitations
TEGNER SCORE
Time frame: 2 years and 15 years after surgery
Daily activities, limitations
LYSHOLM SCORE
Time frame: 2 years and 15 years after surgery
Daily activities, limitations
OBJECTIVE PARAMETER: STREENGHT OF FLEXORS AND EXTENSORS
Time frame: 2 years and 15 years after surgery
Measurements with Biodex isokinetic Dynamometer (deficit (%) at 60 deg/s and 180 deg/s; operated to nonoperated ratio (total work))
OBJECTIVE PARAMETER: AP TRANSLATION (anterior-posterior)
Time frame: 2 years and 15 years after surgery
Measured by KT 1000 and Rollimeter. Laxity was expressed as the difference between injured knee and uninjured knee in millimeters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 8734881Maynard MJ, Deng X, Wickiewicz TL, Warren RF. The popliteofibular ligament. Rediscovery of a key element in posterolateral stability. Am J Sports Med. 1996 May-Jun;24(3):311-6. doi: 10.1177/036354659602400311.
- Background: PubMed 12771815Freeman MA, Pinskerova V. The movement of the knee studied by magnetic resonance imaging. Clin Orthop Relat Res. 2003 May;(410):35-43. doi: 10.1097/01.blo.0000063598.67412.0d.
- Background: PubMed 15749440Browne C, Hermida JC, Bergula A, Colwell CW Jr, D'Lima DD. Patellofemoral forces after total knee arthroplasty: effect of extensor moment arm. Knee. 2005 Apr;12(2):81-8. doi: 10.1016/j.knee.2004.05.006.
- Background: PubMed 11277297Nuno N, Ahmed AM. Sagittal profile of the femoral condyles and its application to femorotibial contact analysis. J Biomech Eng. 2001 Feb;123(1):18-26. doi: 10.1115/1.1339819.
- Background: PubMed 8648311Siu D, Rudan J, Wevers HW, Griffiths P. Femoral articular shape and geometry. A three-dimensional computerized analysis of the knee. J Arthroplasty. 1996 Feb;11(2):166-73. doi: 10.1016/s0883-5403(05)80012-9.
- Background: PubMed 18719975Lonner JH, Jasko JG, Thomas BS. Anthropomorphic differences between the distal femora of men and women. Clin Orthop Relat Res. 2008 Nov;466(11):2724-9. doi: 10.1007/s11999-008-0415-0. Epub 2008 Aug 22.
- Background: PubMed 9802670Griffin FM, Insall JN, Scuderi GR. The posterior condylar angle in osteoarthritic knees. J Arthroplasty. 1998 Oct;13(7):812-5. doi: 10.1016/s0883-5403(98)90036-5.
- Background: PubMed 30955412Yoon KH, Kim JS, Kim SJ, Park M, Park SY, Park SE. Eight-year results of transtibial nonanatomic single-bundle versus double-bundle anterior cruciate ligament reconstruction: Clinical, radiologic outcomes and survivorship. J Orthop Surg (Hong Kong). 2019 May-Aug;27(2):2309499019840827. doi: 10.1177/2309499019840827.
- Background: PubMed 12531750Freedman KB, D'Amato MJ, Nedeff DD, Kaz A, Bach BR Jr. Arthroscopic anterior cruciate ligament reconstruction: a metaanalysis comparing patellar tendon and hamstring tendon autografts. Am J Sports Med. 2003 Jan-Feb;31(1):2-11. doi: 10.1177/03635465030310011501.
- Background: PubMed 28219088Adravanti P, Dini F, de Girolamo L, Cattani M, Rosa MA. Single-Bundle versus Double-Bundle Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial with 6-Year Follow-up. J Knee Surg. 2017 Nov;30(9):898-904. doi: 10.1055/s-0037-1598176. Epub 2017 Feb 20.
- Background: PubMed 8536037Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34. doi: 10.1007/BF01560215.
- Background: PubMed 11912091Shaieb MD, Kan DM, Chang SK, Marumoto JM, Richardson AB. A prospective randomized comparison of patellar tendon versus semitendinosus and gracilis tendon autografts for anterior cruciate ligament reconstruction. Am J Sports Med. 2002 Mar-Apr;30(2):214-20. doi: 10.1177/03635465020300021201.
- Individual participant dataSharing planned: No. Fo now we are not planning to share any participant data to other researchers.
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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.
Mitja Kozic study chair
University Clinical Center Maribor
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 single bundle and ACL reconstruction double bundle in people with Anterior Cruciate Ligament Reconstruction, run by University Medical Centre Maribor at 1 site in Slovenia.
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 4 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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 Slovenia. 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?
Results are not available in the source record.
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?
IKDC SUBJECTIVE SCORE (time frame: before surgery, 2 years and 15 years after surgery). The study lists 5 primary outcomes in all. 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 NCT06303726, which also lists 15 linked publications.
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 12 Mar 2024.