Health TrialsbyHealthPanel

SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

ConditionsAnterior Cruciate Ligament InjuriesAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament Tear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-40
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • ACL Reconstruction with Semitendinosus graft

    Procedure/Surgery

    Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft

  • ACL Reconstruction with Quadriceps tendon-bone graft

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Semitendinosus graftActive comparator 1 intervention
Group B: Quadriceps tendon-bone graftActive comparator 1 intervention

Trial outcomes

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.

Time frame
Pre-operative appointment and 6 months post-operative appointments

Secondary outcomes

1

KOOS

Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment

Time frame
Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
2

IKDC

Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment.

Time frame
Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
3

PAS

Patients will complete the PAS at specific time points to evaluate subjective knee function throughout treatment

Time frame
Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
4

EQ5D

Patients will complete the EQ5D at specific time points to evaluate subjective knee function throughout treatment

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov
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