SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction (SEQUAR)

SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear
• Intervention / Treatment: Procedure: ACL Reconstruction with Semitendinosus graft; Procedure: ACL Reconstruction with Quadriceps tendon-bone graft

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anders Stålman, MD,Phd; Phone Number: 0046736665957; Email: anders.stalman@ki.se

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 11428
      • Recruiting
      • Capio Artro Clinic AB
      • Contact: Anders Stålman, MD, PhD
      • Principal Investigator: Vasileios Sarakatsianos, MD
      • Principal Investigator: Daniel Castellanos, MD
      • Principal Investigator: Anders Stålman, MD,PhD
      • Principal Investigator: Mikael Östlin, MD
      • Principal Investigator: Joanna Kvist, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pre-injury Tegner Activity Scale≥7
• 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:

• Previous knee injury with symptoms before ACL injury
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Semitendinosus graft; Participants receive the Semitendinosus Graft technique during ACL reconstruction.	Procedure: ACL Reconstruction with Semitendinosus graft; Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft; Other Names: ACL-R with Semitendinosus graft; Semitendinosus ACL-R
Active Comparator: Quadriceps tendon-bone graft; Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction.	Procedure: ACL Reconstruction with Quadriceps tendon-bone graft; Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft; Other Names: ACL-R with Quadriceps tendon-bone graft; Quad tendon-bone ACL-R

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC	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
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
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
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
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Anders Stålman, MD,PhD, Karolinska Institutet; Principal Investigator: Mikael Östin, MD, Capio Artro Clinic AB; Principal Investigator: Vasileios Sarakatsianos, MD, Karolinska Institutet; Principal Investigator: Joanna Kvist, PhD, Karolinska Institutet; Principal Investigator: Daniel Castellanos, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2035

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: DNR 2019-03359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No