SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Injuries Clinical Trial

— SEQUAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295148
• Other study ID #: DNR 2019-03359
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: Anders Stålman, MD,Phd
• Phone: 0046736665957
• Email: anders.stalman[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 Sweden's standard choice of graft, semitendinosus graft in ACL-R in higher level 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. Stratifying according to gender will be done with 40% female and 60 % males, as this represent the prevalence of ACL reconstruction in our clinic and in the Swedish ACL registry. It is known the females have a higher rerupture rate and lower subjective outcome. Inclusion will continue until we have 100 individuals in each group according to the stratification. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

Inclusion Criteria:

• Primary ACL reconstruction for patients with Tegner score equal or higher than 7 before injury.

Exclusion Criteria:

• Multiligament knee injury

• Former knee operation

• Former fracture

• Inflammatory disease

• More than one ligamentous injury in the same knee requiring reconstructive surgery

• Former ACL injury in the contralateral knee

• Reconstruction of ACL in the contralateral knee during the study follow up period

• Lack av baseline pre- or postoperative data (KT-1000, KOOS, Lysholm Score, EQ-5D)

• Any other situation preventing patient from participating in extensive follow up.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Anterior Cruciate Ligament Tear
• Rupture

Intervention

Procedure:
• ACL Reconstruction with Semitendinosus graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
• ACL Reconstruction with Quadriceps tendon-bone graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft

Locations

Country	Name	City	State
Sweden	Capio Artro Clinic AB	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline 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
Primary	Change from Baseline KOOS (the Knee Injury and Osteoarthritis Outcome Score) at 24 months	Patients will complete the KOOS surveys at pre-operatively and at 2 years time post-operatively to evaluate subjective knee function	Pre-operative appointment and 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Lysholm score	Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment	Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Biodex Isokinetic Measurement	Patients will undergo Biodex Isokinetic measurement at specific time points to muscle strength throughout treatment.	6 months and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	ACL re-operation	ACL reconstruction will be evaluated by re-operation rate during a 10 year period	10 years
Secondary	Graft maturity	Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively.	9 months
Secondary	10 year X-Ray	Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years.	10 years