SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction
NCT ID: NCT04295148
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2020-02-10
2035-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Semitendinosus graft
Participants receive the Semitendinosus Graft technique during ACL reconstruction.
ACL Reconstruction with Semitendinosus graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
Quadriceps tendon-bone graft
Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction.
ACL Reconstruction with Quadriceps tendon-bone graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft
Interventions
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ACL Reconstruction with Semitendinosus graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
ACL Reconstruction with Quadriceps tendon-bone graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Intended return to sports to prior sport and Tegner Activity Scale Level
* Time between injury and inclusion not more than 6 months
* MR verified ACL rupture
Exclusion Criteria
* Neurological disease, inflammatory disease, connective tissue disease or balance disorder
* Previous lower limb fracture or surgery
* Laxity in the medial collateral ligament (MCL) and lateral collateral ligament (LCL) \> grade 1
* PCL rupture or Multiligament knee injury (MLKI)
* Radiographic sign of osteoarthritis (OA)
* Previous knee surgery or ligament injury in contralateral knee
* Beighton score ≥ 5
16 Years
40 Years
ALL
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Anders Stalman
Senior Consultant, Principal Investigator, Ph.D.
Principal Investigators
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Anders Stålman, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Mikael Östin, MD
Role: PRINCIPAL_INVESTIGATOR
Capio Artro Clinic AB
Vasileios Sarakatsianos, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Joanna Kvist, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Daniel Castellanos, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Capio Artro Clinic AB
Stockholm, Stockholm County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Anders Stålman, MD, PhD
Role: primary
References
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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.
Other Identifiers
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DNR 2019-03359
Identifier Type: -
Identifier Source: org_study_id
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