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Aim: Comparison of tendon to bone ingrowth in bone tunnels and intra-articular remodeling of the graft after anterior cruciate ligament surgery with a muscle-tendon graft and those with a tendon graft. Subjects and methods: It is a single-blind prospective randomized study that would include at least 40 patients with an anterior cruciate ligament rupture. Patients would be randomly divided into two groups of minimally 20 patients each. Patients in the first study group would undergo ACL reconstruction with a muscle-tendon graft, while patients in the control group would be treated with the standard method of ACL reconstruction with a tendon graft.
Expected contribution to the field: The assumption is that the obtained results could enable a better understanding of the contribution of remaining muscle fibers on the tendon in anterior cruciate ligament reconstruction operations to the tendon to bone ingrowth and intra-articular remodeling of the graft of operated patients.
This is a prospective, randomized clinical study conducted at Dubrava University Hospital. At least 40 patients aged 18 to 50 years with clinically and MRI-confirmed anterior cruciate ligament rupture and indication for concomitant lateral tenodesis will be enrolled. Participants will be randomly assigned in a 1:1 ratio to undergo arthroscopic all-inside ACL reconstruction using either a muscle-tendon semitendinosus graft (experimental group) or a standard tendon-only semitendinosus graft (control group). All surgical procedures will be performed by the same surgeon and supplemented with modified Lemaire lateral tenodesis.
Clinical assessments will be performed preoperatively and at 6 weeks, 6 and 12 months postoperatively and will include validated patient-reported outcome measures (EQ-5D and KOOS) and a non-validated Croatian version of the IKDC Subjective Knee Evaluation Form. Knee stability will be assessed 12 months postoperatively using a digital Lachmeter device.
Magnetic resonance imaging of the operated knee will be performed at 6 weeks, 6 and 12 months using a standardized 3T MRI protocol including proton density sequences and T2 mapping. Intra-articular graft remodeling will be assessed using the signal-to-noise quotient method, with standardized regions of interest placed at the proximal, middle, and distal portions of the intra-articular graft and at the posterior cruciate ligament. Tendon-to-bone healing will be evaluated by measuring femoral and tibial tunnel diameters and calculating percentage tunnel widening relative to intraoperative tunnel size.
All participants will follow identical postoperative rehabilitation protocols. MRI analysis will be performed by two experienced musculoskeletal radiologists blinded to group allocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tendon | Active Comparator | Intervention Name: Tendon-only ST graft Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus tendon graft without meniscus repair. Details: Standard tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Anesthesia per protocol Standardized post-op rehab |
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| Tendon + meniscus | Active Comparator | Intervention Name: Tendon-only ST graft + meniscus repair Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus tendon graft with concurrent meniscus suture. Details: Standard tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Meniscus repair as needed Anesthesia per protocol Standardized post-op rehab |
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| Muscle tendon | Active Comparator | Intervention Name: Muscle-tendon ST graft Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus graft preserving muscle fibers, without meniscus repair. Details: Muscle-tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Anesthesia per protocol Standardized post-op rehab |
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| Muscle tendon + meniscus | Active Comparator | Intervention Name: Muscle-tendon ST graft + meniscus repair Procedure/Surgery: Arthroscopic all-inside ACL reconstruction using an autologous semitendinosus graft preserving muscle fibers, with meniscus repair. Details: Muscle-tendon graft preparation and fixation Tunnel creation and concomitant lateral tenodesis Meniscus repair technique as needed Anesthesia per protocol Standardized post-op rehab |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL reconstruction | Procedure | Participants will undergo arthroscopic all-inside anterior cruciate ligament reconstruction using an autologous semitendinosus graft. In the experimental intervention, a muscle-tendon semitendinosus graft is used, with preservation of muscle fibers on the tendon. In the control intervention, a standard tendon-only semitendinosus graft is used. In both groups, graft preparation, tunnel creation, fixation technique, and concomitant lateral tenodesis are identical, and all procedures are performed by the same surgeon following a standardized protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| SNQ | To analyze and compare T2 signal-to-noise ratio values on magnetic resonance imaging at 6 weeks, 6 and 12 months postoperatively within and between the two study groups. The SNQ is calculated as the ratio of the graft T2 signal intensity to the signal intensity of a reference tissue on MRI. Higher SNQ values indicate higher graft signal, which corresponds to lower graft maturity/quality. Scale: Continuous numerical value (exact values depend on MRI signal calibration). | 6 weeks, 6 and 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Tunnel Diameter - Femur | Description: The diameter of the femoral bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter. Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening | 6 weeks, 6 months, 12 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marin Glavčić, MD | Contact | +385 1 290 2571 | mglavcic@kbd.hr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital Dubrava | Recruiting | Zagreb | 10000 | Croatia |
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| Bone Tunnel Diameter - Tibia |
Description: The diameter of the tibial bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter. Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening. |
| 6 weeks, 6 months, 12 months postoperatively |
| Knee Stability - Anterior Tibial Translation | Description: The anterior-posterior stability of the operated knee measured with the Lachmeter device at 12 months postoperatively. Units: Millimeters (mm) of anterior tibial translation Directionality: Higher values indicate greater laxity (worse stability) | 12 months postoperatively |
| KOOS - Pain Subscale | Description: Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale, assessing knee pain. Scale: 0-100 (0 = extreme pain, 100 = no pain; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Symptoms Subscale | Description: KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness). Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Activities of Daily Living (ADL) Subscale | Description: KOOS - ADL subscale, assessing functional ability in daily activities. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Sports/Recreation Subscale | Description: KOOS - Sports/Recreation subscale, assessing function during sport or recreational activity. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| KOOS - Quality of Life (QoL) Subscale | Description: KOOS - QoL subscale, assessing knee-related quality of life. Scale: 0-100 (0 = extreme problem, 100 = no problem; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |
| IKDC-SKF (International Knee Documentation Committee - Subjective Knee Form) | Description: Patient-reported measure of knee function, symptoms, and sports activity. Scale: 0-100 (0 = worst knee function, 100 = best knee function; higher scores = better outcome) | Before surgery, 6 weeks, 6 months, 12 months postoperatively |