Anterior Cruciate Ligament InjuriesSEQUARNCT04295148
SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction
A study testing ACL Reconstruction with Semitendinosus graft and ACL Reconstruction with Quadriceps tendon-bone graft in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- What is being tested?
- ACL Reconstruction with Semitendinosus graft and ACL Reconstruction with Quadriceps tendon-bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 10 Feb 2020to 31 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Capio Artro Clinic AB
Stockholm, Stockholm County, 11428
Anders Stålman, MD, PhD
Vasileios Sarakatsianos, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Being tested
- ACL Reconstruction with Semitendinosus graft, ACL Reconstruction with Quadriceps tendon-bone graft
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Reconstruction with Semitendinosus graftProcedure or surgery
Also called ACL-R with Semitendinosus graft, Semitendinosus ACL-R
Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
ACL Reconstruction with Quadriceps tendon-bone graftProcedure or surgery
Also called ACL-R with Quadriceps tendon-bone graft, Quad tendon-bone ACL-R
Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft
| Study group | Role | What they receive |
|---|---|---|
| Semitendinosus graft | Active comparator | Participants receive the Semitendinosus Graft technique during ACL reconstruction. Receives: Procedure: ACL Reconstruction with Semitendinosus graft |
| Quadriceps tendon-bone graft | Active comparator | Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction. Receives: Procedure: ACL Reconstruction with Quadriceps tendon-bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-operative appointment and 6 months post-operative appointments
Secondary outcomes (21)
KOOS
Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment
Measured: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
IKDC
Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 10 years
ACL re-operation
ACL reconstruction will be evaluated by re-operation rate during a 10 year period
Measured: 10 years
Graft maturity
Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively.
Measured: 9 months
10 year X-Ray
Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Feb 2020
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Stalman, Karolinska Institutet
- Investigators
- Anders Stålman, MD,PhD, Principal investigator, Karolinska InstitutetMikael Östin, MD, Principal investigator, Capio Artro Clinic ABVasileios Sarakatsianos, MD, Principal investigator, Karolinska InstitutetJoanna Kvist, PhD, Principal investigator, Karolinska InstitutetDaniel Castellanos, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295148
- Sponsor's protocol ID
- DNR 2019-03359
- Acronym
- SEQUAR
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2020
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41083992
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04295148
- Acronym / sponsor ID
- SEQUAR / DNR 2019-03359
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2035 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semitendinosus graft | Active comparator | Procedure: ACL Reconstruction with Semitendinosus graftParticipants receive the Semitendinosus Graft technique during ACL reconstruction. |
| Quadriceps tendon-bone graft | Active comparator | Procedure: ACL Reconstruction with Quadriceps tendon-bone graftParticipants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Reconstruction with Semitendinosus graftAlso: ACL-R with Semitendinosus graft, Semitendinosus ACL-RParticipants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft | Procedure or surgery | Semitendinosus graft |
| ACL Reconstruction with Quadriceps tendon-bone graftAlso: ACL-R with Quadriceps tendon-bone graft, Quad tendon-bone ACL-RParticipants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft | Procedure or surgery | Quadriceps tendon-bone graft |
Primary outcome
KT-1000 Knee Laxity at 6 months
Time frame: Pre-operative appointment and 6 months post-operative appointments
The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm.
21 secondary outcomes
KOOS
Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
IKDC
Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
PAS
Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
EQ5D
Time frame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
Tegner Activity Score
Time frame: Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments
ACL-RSI
Time frame: 6 months and 12 months, post-operative appointments
Return to Sports Questionnaire
Time frame: 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments
Werner anterior knee pain score
Time frame: 6 weeks, 6 months, 9 months, and 12 months
Kartus anterior knee pain score
Time frame: 6 weeks, 6 months, 9 months, and 12 months
Graft site morbidity questionnaire
Time frame: 6 weeks, 6 months, 12 months, 24 months
Goniometric measurement: Knee extension and flexion
Time frame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months
Measurement of circumference of the knee
Time frame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months
Biodex Isokinetic Measurement
Time frame: 6 months, 9 months and 12 months
Functional knee tests
Time frame: 6 months, 9 months and 12 months
Lachmans test
Time frame: Pre-operative appointment , 6 months, 9 months and 12 months
Pivot shift test
Time frame: Pre-operative appointment , 6 months, 9 months and 12 months
Time to Return to Sports Rates
Time frame: 6 months, 9 months, 12 months, 18 months, 24 months
Graft failure rate or ACL re-rupture
Time frame: 10 years
ACL re-operation
Time frame: 10 years
Graft maturity
Time frame: 9 months
10 year X-Ray
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 41083992Castellanos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Stålman, MD,PhD principal investigator
Karolinska Institutet
Mikael Östin, MD principal investigator
Capio Artro Clinic AB
Vasileios Sarakatsianos, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Reconstruction with Semitendinosus graft and ACL Reconstruction with Quadriceps tendon-bone graft in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Stålman, MD,Phd (0046736665957, anders.stalman@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KT-1000 Knee Laxity at 6 months (time frame: Pre-operative appointment and 6 months post-operative appointments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.