SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

NCT04295148 | Recruiting

• 1 other identifier: DNR 2019-03359
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• KOOS

  Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments

• IKDC

  Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments

• PAS

  Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments

• EQ5D

  Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments

• Tegner Activity Score

  Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments

Study Arms (2)

Semitendinosus graft

ACTIVE COMPARATOR

Participants receive the Semitendinosus Graft technique during ACL reconstruction.

Procedure: ACL Reconstruction with Semitendinosus graft

Quadriceps tendon-bone graft

ACTIVE COMPARATOR

Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction.

Procedure: ACL Reconstruction with Quadriceps tendon-bone graft

Interventions

ACL Reconstruction with Semitendinosus graft PROCEDURE

Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft

Also known as: ACL-R with Semitendinosus graft, Semitendinosus ACL-R

Semitendinosus graft

ACL Reconstruction with Quadriceps tendon-bone graft PROCEDURE

Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft

Also known as: ACL-R with Quadriceps tendon-bone graft, Quad tendon-bone ACL-R

Quadriceps tendon-bone graft

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pre-injury Tegner Activity Scale≥7
• Intended return to sports to prior sport and Tegner Activity Scale Level
• MR verified ACL rupture

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Capio Artro Clinic AB

Stockholm, Stockholm County, 11428, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 41083992 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Stålman, MD,Phd

CONTACT

0046736665957; anders.stalman@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Principal Investigator, Ph.D.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 4, 2020
• Study Start: February 10, 2020
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2035
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)