University hospital Dubrava
Zagreb, 10000, Croatia
Location status: Recruiting
NCT Number: NCT07404046
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Zagreb, 10000, Croatia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 weeks, 6 and 12 months postoperatively
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).
Time frame: 6 weeks, 6 months, 12 months postoperatively
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
Time frame: 6 weeks, 6 months, 12 months postoperatively
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.
Time frame: 12 months postoperatively
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)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
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)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
Description: KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness).
Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
Description: KOOS - ADL subscale, assessing functional ability in daily activities.
Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
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)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
Description: KOOS - QoL subscale, assessing knee-related quality of life. Scale: 0-100 (0 = extreme problem, 100 = no problem; higher scores = better outcome)
Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively
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)
Contact information is provided by the study sponsor or research team.
University Hospital Dubrava
Other
Comparison of Bone Ingrowth and Intra-articular Remodeling of Autologous Tendon and Muscle-tendon Semitendinosus Graft After Arthroscopic Anterior Cruciate Ligament Reconstruction Surgery
Acronym: CandyStripe
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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