Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
Conditions
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. 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.
Interventions
PROCEDUREACL Reconstruction with Semitendinosus graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
PROCEDUREACL Reconstruction with Quadriceps tendon-bone graft
Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KT-1000 Knee Laxity at 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft maturity | 9 months | Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively. |
| 10 year X-Ray | 10 years | Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years. |
| KOOS | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment |
| IKDC | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment. |
| PAS | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | Patients will complete the PAS at specific time points to evaluate subjective knee function throughout treatment |
| EQ5D | Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments | Patients will complete the EQ5D at specific time points to evaluate subjective knee function throughout treatment |
| Tegner Activity Score | Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments | Patients will complete the Tegner Activity score at specific time points to evaluate level of sports activity postoperatively. |
| ACL-RSI | 6 months and 12 months, post-operative appointments | Patients will complete the ACL-RSI surveys at specific time points to evaluate self efficacy and readiness to return to sports throughout treatment |
| Return to Sports Questionnaire | 6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments | 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 |
| Werner anterior knee pain score | 6 weeks, 6 months, 9 months, and 12 months | Patients will complete Werner anterior knee pain scores at specific time points to evaluate graft site pain/morbidity throughout treatment |
| ACL re-operation | 10 years | ACL reconstruction will be evaluated by re-operation rate during a 10 year period |
| Graft site morbidity questionnaire | 6 weeks, 6 months, 12 months, 24 months | Patients will complete additional survey questions at specific time points to evaluate graft site pain/morbidity throughout treatment |
| Goniometric measurement: Knee extension and flexion | 2 weeks, 6 weeks, 6 months, 9 months and 12 months | Patients will undergo goniometric measurement at specific time points to evaluate knee moment throughout treatment. |
| Measurement of circumference of the knee | 2 weeks, 6 weeks, 6 months, 9 months and 12 months | 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. |
| Biodex Isokinetic Measurement | 6 months, 9 months and 12 months | Patients will undergo Biodex Isokinetic measurement at specific time points to muscle strength throughout treatment. |
| Functional knee tests | 6 months, 9 months and 12 months | Patients will undergo functional knee test (ie one legged jump and crossover jump) at specific time points to evaluate functional knee movement throughout treatment. |
| Lachmans test | Pre-operative appointment , 6 months, 9 months and 12 months | 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. |
| Pivot shift test | Pre-operative appointment , 6 months, 9 months and 12 months | 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. |
| Time to Return to Sports Rates | 6 months, 9 months, 12 months, 18 months, 24 months | Time to return to sports will be evaluated through Return to Sport surveys at specific time points throughout treatment |
| Graft failure rate or ACL re-rupture | 10 years | ACL reconstruction will be evaluated by graft failure rate or ACL re-rupture during a 10 year period |
| Kartus anterior knee pain score | 6 weeks, 6 months, 9 months, and 12 months | Patients will complete Kartus anterior knee pain score at specific time points to evaluate graft site pain/morbidity throughout treatment |
Countries
Sweden
Contacts
Primary ContactAnders Stålman, MD,Phd
Outcome results
None listed