Clinical trial NCT04295148: SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction
Official title: SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Rupture
Anterior Cruciate Ligament Tear
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. Patients will be followed up during a 2-year period.

Both grafts will be compared post operatively as to laxity, PROM, 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. Both methods are well-known and continually registered in the Swedish ACL Registry.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline KT-1000 Knee Laxity at 6 months
timeFrame: Pre-operative appointment and 6 months post-operative appointments
measure: Change from Baseline KOOS (the Knee Injury and Osteoarthritis Outcome Score) at 24 months
timeFrame: Pre-operative appointment and 24 months
Secondary outcomes:
measure: IKDC
timeFrame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
measure: PAS
timeFrame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
measure: KOOS
timeFrame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
measure: EQ5D
timeFrame: Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments
measure: Tegner Activity Score
timeFrame: Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments
measure: ACL-RSI
timeFrame: 6 months and 12 months, post-operative appointments
measure: Return to Sports Questionnaire
timeFrame: 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments
measure: Werner anterior knee pain score
timeFrame: 6 weeks, 6 months, 9 months, and 12 months
measure: Kartus anterior knee pain score
timeFrame: 6 weeks, 6 months, 9 months, and 12 months
measure: Graft site morbidity questionnaire
timeFrame: 6 weeks, 6 months, 12 months, 24 months
measure: Goniometric measurement: Knee extension and flexion
timeFrame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months
measure: Measurement of circumference of the knee
timeFrame: 2 weeks, 6 weeks, 6 months, 9 months and 12 months
measure: Biodex Isokinetic Measurement
timeFrame: 6 months, 9 months and 12 months
measure: Functional knee tests
timeFrame: 6 months, 9 months and 12 months
measure: Lachmans test
timeFrame: Pre-operative appointment , 6 months, 9 months and 12 months
measure: Pivot shift test
timeFrame: Pre-operative appointment , 6 months, 9 months and 12 months
measure: Time to Return to Sports Rates
timeFrame: 6 months, 9 months, 12 months, 18 months, 24 months
measure: Graft failure rate or ACL re-rupture
timeFrame: 10 years
measure: ACL re-operation
timeFrame: 10 years
measure: Graft maturity
timeFrame: 9 months
measure: 10 year X-Ray
timeFrame: 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Capio Artro Clinic AB
Study officials:
affiliation: Karolinska Institutet
name: Anders Stålman, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Capio Artro Clinic AB
name: Mikael Östin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Vasileios Sarakatsianos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Joanna Kvist, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Daniel Castellanos, MD
role: PRINCIPAL_INVESTIGATOR
References: