Injury of the Anterior Cruciate Ligament (ACL) Clinical Trial
— RetroBRACE IIOfficial title:
RetroBRACE II: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction - Considering Socioeconomic Aspects and Return to Work
| Verified date | January 2023 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct comparison to ACL reconstruction and to identify potential deficits compared to the contralateral healthy side as well as with a knee-healthy age-matched collective. In addition, socio-economic aspects such as return to work and sports and treatment cost will be compared between both techniques.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | July 14, 2022 |
| Est. primary completion date | July 14, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - Patients: 2 years since ACL reconstruction with autologous hamstring tendon - Control subjects: no previous injury to the meniscus or the ligament apparatus of the knee Exclusion Criteria: - BMI > 35 kg / m2 - neuromuscular diseases that affect lower limb movement - Inability to give informed consent - Patients: previous injury or surgical treatment of the opposite side within the past 2 years and the injured leg within the past 6 months; other pathologies that affect the mobility of the knee |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Orthopaedics and Traumatology, University Hospital Basel | Basel |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Range of Motion (ROM) of the knee | Range of Motion (ROM) of the knee | at baseline (2 years after surgery) | |
| Primary | Isokinetic muscle strength | Isokinetic muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). The maximum isokinetic flexion and extension torques will be measured on the knee between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum torques will be recorded for each direction of movement and normalized to body weight. | approx. 30 minutes at baseline (2 years after surgery) | |
| Primary | Proprioception (joint position sense) | Proprioception will be measured bilaterally with a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) using an active joint position sense protocol. The participants will be positioned on the dynamometer with knee and hip angles of 90°. They will then actively stretch their knees up to target angles of 60° or 30° flexion. Subjects will be asked to remember this position and then stretch their knees from a starting position of 90° flexion and, as soon as they think they have reached the target angle, push a stop button. The deviation between the perceived angle and the actual target angle will be calculated. | approx. 30 minutes at baseline (2 years after surgery) | |
| Primary | Gait analysis | Gait analysis performed on a treadmill with an integrated pressure plate and a walkway with two integrated force plates. Kinematic and EMG data collected using a 9-camera Vicon system and a 12-channel EMG system. To measure 3D joint angles, reflective markers will be attached to defined anatomical locations on the pelvis and legs.10 Bipolar surface electrodes will be attached bilaterally to the glutaeus medius, vastus medialis and lateralis, semitendinosus, tibialis anterior and gastrocnemius medialis muscles according to the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Study participants walk at self-selected speed. In addition, patients walk on treadmill at a self-selected speed, at a speed of 1.2 m/s and to run at self-selected speed and if possible at 2.2m/s. Kinematic and kinetic, EMG and pressure data recorded for all testing conditions. | approx. 60 minutes at baseline (2 years after surgery) | |
| Primary | Postural stability | The stability of posture and balancing will be determined by the variability of movement in the horizontal plane and the length of the pressure line during two 30-second single- leg stands (on solid surface and on foam surface) on a force plate (Kistler 9260AA6, Kistler AG, Winterthur, Switzerland; sampling frequency, 2400 Hz) and mathematical calculations | at baseline (2 years after surgery) | |
| Primary | Functional activity score to determine the ability "return to activity" | Functional activity tests include the Y-balance test, single-leg jump for distance, side jumps for time (30 seconds) and precision over a distance of 40 cm (side hop). The quantity of movement of these functional scores will be calculated. | at baseline (2 years after surgery) | |
| Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee Problems. | at baseline (2 years after surgery) | |
| Secondary | International Knee Documentation Committee (IKDC) | The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function | at baseline (2 years after surgery) | |
| Secondary | Tegner Activity Score | Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. | at baseline (2 years after surgery) | |
| Secondary | EuroQoL-5D-5L (EQ 5D 5L) | EQ-5D-5L questionnaire measuring generic health Status; descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions). | at baseline (2 years after surgery) | |
| Secondary | ACL- RSI Score | The ALC-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each. It is considered that for a normal population without knee condition, the score is between 80 and 90% | at baseline (2 years after surgery) | |
| Secondary | Time to return to work | Socioeconomic aspect: time to return to work | at baseline (2 years after surgery) | |
| Secondary | Time to return to sports | Time to return to sports | at baseline (2 years after surgery) |