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Randomized control trial comparing two different Anterior Cruciate Ligament (ACL) grafts in Anterior Cruciate Ligament Reconstruction: the semitendinosus hamstrings graft and the quadriceps graft. Capio Artro Clinic (Stockholm) has vast experience in ACL surgery using both semitendinosus and quadriceps grafts.
The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with the most common choice of graft, semitendinosus hamstrings graft in ACL-R in athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry.
Both grafts will be compared post operatively as to knee laxity (primary outcome), PROMs, as well as measure graft site morbidity, Return to Sports rate, and the post-operative rehab. At 9 months we will also preform a MRI scan to determine graft maturity. 5-year and 10-year data will also be acquired through the Swedish ACL-registry and Lysholm score and Tegner Activity Level score. At 10-year a plain weight baring X-ray will be preformed to evaluate development of osteoarthritis.
The study design is a prospective randomized study with equal groups:
Semitendinosus graft (=100) and Quadriceps tendon graft (n=100). According to historical material from Capio Artro Clinic (Stockholm) the following power calculation has been made: Significance lever 5 percent (p=0.05) and power is 80%. The difference between the groups is 1 mm knee laxity with KT-1000 which would give an effect size of 0,44 or less compared to an average effect size (0,50). 85 individuals will be needed in each group in the statistical analysis. Although no stratification for sex will be performed, our aim is to have a balanced representation of sex that reflects the typical patient population for this condition at the clinic, with a distribution of 40% females and 60% males across both groups. Inclusion will continue until we have at least 100 individuals in each group. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.
Initially, the study was designed to have two primary outcome measures: KT-1000 knee laxity at 6 months and KOOS at 24 months. However, the study is only powered for the first outcome (Knee Laxity measured with KT-1000), therefore KOOS will be followed as a secondary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semitendinosus graft | Active Comparator | Participants receive the Semitendinosus Graft technique during ACL reconstruction. |
|
| Quadriceps tendon-bone graft | Active Comparator | Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL Reconstruction with Semitendinosus graft | Procedure | Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| KT-1000 Knee Laxity at 6 months | The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm. | Pre-operative appointment and 6 months post-operative appointments |
| Measure | Description | Time Frame |
|---|---|---|
| KOOS | Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments |
| IKDC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anders Stålman, MD,Phd | Contact | 0046736665957 | anders.stalman@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Anders Stålman, MD,PhD | Karolinska Institutet | Principal Investigator |
| Mikael Östin, MD | Capio Artro Clinic AB | Principal Investigator |
| Vasileios Sarakatsianos, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capio Artro Clinic AB | Recruiting | Stockholm | Stockholm County | 11428 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41083992 | Derived | Castellanos Dolk D, Sarakatsianos V, Worner T, Ostin M, Cristiani R, Kvist J, Stalman A. Semitendinosus vs quadriceps tendon autograft in anterior cruciate ligament reconstruction (SEQUAR): protocol for a prospective randomized controlled trial. BMC Musculoskelet Disord. 2025 Oct 13;26(1):951. doi: 10.1186/s12891-025-09183-w. |
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|
| ACL Reconstruction with Quadriceps tendon-bone graft | Procedure | Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft |
|
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Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment.
| Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments |
| PAS | Patients will complete the PAS at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments |
| EQ5D | Patients will complete the EQ5D at specific time points to evaluate subjective knee function throughout treatment | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments |
| Tegner Activity Score | Patients will complete the Tegner Activity score at specific time points to evaluate level of sports activity postoperatively. | Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments |
| ACL-RSI | Patients will complete the ACL-RSI surveys at specific time points to evaluate self efficacy and readiness to return to sports throughout treatment | 6 months and 12 months, post-operative appointments |
| Return to Sports Questionnaire | Patients will complete the a Return to Sports Questionnaire at specific time points to evaluate return to sports after 6 and 12 months throughout treatment | 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments |
| Werner anterior knee pain score | Patients will complete Werner anterior knee pain scores at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 9 months, and 12 months |
| Kartus anterior knee pain score | Patients will complete Kartus anterior knee pain score at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 9 months, and 12 months |
| Graft site morbidity questionnaire | Patients will complete additional survey questions at specific time points to evaluate graft site pain/morbidity throughout treatment | 6 weeks, 6 months, 12 months, 24 months |
| Goniometric measurement: Knee extension and flexion | Patients will undergo goniometric measurement at specific time points to evaluate knee moment throughout treatment. | 2 weeks, 6 weeks, 6 months, 9 months and 12 months |
| Measurement of circumference of the knee | Circumference of the knee will be measured at mid-patella and 15 cm above superior border of the patella. They will be compared with the contralateral knee to compare knee swelling. | 2 weeks, 6 weeks, 6 months, 9 months and 12 months |
| Biodex Isokinetic Measurement | Patients will undergo Biodex Isokinetic measurement at specific time points to muscle strength throughout treatment. | 6 months, 9 months and 12 months |
| Functional knee tests | Patients will undergo functional knee test (ie one legged jump and crossover jump) at specific time points to evaluate functional knee movement throughout treatment. | 6 months, 9 months and 12 months |
| Lachmans test | Patients will undergo passive accessory stability tests Lachmans test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment. | Pre-operative appointment , 6 months, 9 months and 12 months |
| Pivot shift test | Patients will undergo passive accessory stability tests pivot shift test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment. | Pre-operative appointment , 6 months, 9 months and 12 months |
| Time to Return to Sports Rates | Time to return to sports will be evaluated through Return to Sport surveys at specific time points throughout treatment | 6 months, 9 months, 12 months, 18 months, 24 months |
| Graft failure rate or ACL re-rupture | ACL reconstruction will be evaluated by graft failure rate or ACL re-rupture during a 10 year period | 10 years |
| ACL re-operation | ACL reconstruction will be evaluated by re-operation rate during a 10 year period | 10 years |
| Graft maturity | Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively. | 9 months |
| 10 year X-Ray | Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years. | 10 years |
| Karolinska Institutet |
| Principal Investigator |
| Joanna Kvist, PhD | Karolinska Institutet | Principal Investigator |
| Daniel Castellanos, MD | Karolinska Institutet | Principal Investigator |
| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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