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Tundra lists 3 LET clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07041242
Outcomes and Complication Rates of Anterior Cruciate Ligament Reconstruction Using the "Over-the-top" Technique Combined With Lateral Extra-articular Tenodesis in Patients Over 50 Years Old, Compared With a Control Group of Patients Under 30
The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee, and its injury is among the most common soft tissue injuries of the knee. Surgical reconstruction of the ACL can be performed using various techniques and different types of tissue grafts, including both autografts and allografts. Although ACL reconstruction is a widely performed surgical procedure in young and physically active individuals-typically patients under 30 years of age-to promote return to sports and prevent early onset of osteoarthritic degeneration, the surgical approach has historically been less common in patients over the age of 50. This is largely due to the lower functional demands typically observed in older patients. However, with increasing life expectancy and a corresponding rise in functional demands among older individuals, the surgical approach to ACL reconstruction has been progressively reconsidered in the over-50 population. Several recent studies have aimed to evaluate the outcomes of ACL reconstruction in older adults, showing promising results in terms of both recurrence rates and complication rates. At the II Clinic of the Rizzoli Orthopaedic Institute, under the direction of Professor Zaffagnini, the preferred technique for ACL reconstruction is the "single-bundle over-the-top technique using gracilis and semitendinosus tendons, combined with a lateral extra-articular tenodesis (LET)." LET is an additional surgical step performed alongside ACL reconstruction, which has shown excellent results, especially in young patients at high risk of reinjury. Specifically, clinical data have shown that adding LET to ACL reconstruction can reduce the failure rate by approximately 30%, significantly improve knee stability, and enable a faster return to sports-all without increasing the rate of complications compared to the standard isolated ACL reconstruction technique. Given these encouraging results in terms of safety and reduced failure rates, the combined ACL + LET procedure has historically been used at the Rizzoli Orthopaedic Institute for all patients, including those over 50 years of age. The consistent use of this technique allows for the creation of a homogeneous patient cohort, all treated with the same surgical approach. This also enables the formation of two comparable patient groups-one over 50 and one under 30-both treated with the same technique, allowing for a meaningful comparison of primary and secondary endpoints. While several studies have aimed to compare ACL reconstruction outcomes in older populations with those in younger cohorts, to date, there are no studies in the literature that specifically assess the outcomes and complication rates of ACL reconstruction using the over-the-top technique combined with LET in patients over 50, and compare them with those of younger patients undergoing the same surgical procedure. Given the growing demand for ACL reconstruction in older patients, we believe it is important to evaluate outcomes in patients over 50 and compare them with a younger cohort, to determine whether the over-the-top + LET technique may be a valid therapeutic option not only for young patients but also for older adults. Of particular interest is the assessment of the reduced risk of failure and complication rate of the ACL + LET technique performed in over-50 patients, to determine whether the excellent clinical outcomes observed in younger individuals are also confirmed in an older population.
Gender: All
Ages: 18 Years - Any
Updated: 2025-07-17
1 state
NCT06868147
Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.
Several techniques for revision of anterior cruciate ligament (ACL) reconstruction and different types of grafts have been used over the years. These include single-bundle techniques, double-bundle techniques, and single-bundle techniques with external tenodesis. We also distinguish between the use of autografts and grafts from donors, or allografts. The choice of surgical technique and graft type is strongly influenced by the progression of damage characterizing these patients (meniscal, chondral, or ligamentous), the surgical decisions made during the initial surgery (graft used, orientation, and number of bone tunnels), or any complications that occurred. The use of a specific type of graft is heavily dependent on its availability: it is likely that the first-choice graft for some surgeons may be unavailable because it has already been used. The use of allografts is now commonly accepted by the scientific community, with the Achilles tendon standing out for its biomechanical properties and size. Unlike autografts, it does not damage the patient's ligamentous tissue, which is thus preserved. Since osteoarthritis is one of the most debated consequences of anterior cruciate ligament revision, an analysis of the results is essential to provide a clearer understanding of the risks and benefits associated with the different types of procedures.
Gender: All
Ages: 18 Years - 50 Years
Updated: 2025-07-01
NCT06885372
Long-term Follow up of the Stability 1 Trial
From 2014-2017, across 7 Canadian and 2 European sites, we randomized 618 patients at high-risk of re-injury, to anterior cruciate ligament reconstruction (ACLR) with or without a lateral extraarticular tenodesis (LET) and demonstrated that the addition of the LET reduced the risk of instability (RRR=0.38; 95% Confidence Interval (CI), 0.21-0.52; P=0.0001) and graft re-rupture (RRR, 0.67; 95% CI, 0.36-0.83; P=0.001). As a result, practice has changed; there has been a large increase in the proportion of orthopaedic surgeons recommending the addition of an LET at the time of ACLR and an increase in the number of patients requesting an LET from their surgeon. There is some weak evidence suggesting that in the longer term, the LET may increase the risk of developing osteoarthritis (OA) in that knee. Knee OA affects over 4.4 million Canadians and the number of younger adults being diagnosed with knee OA is growing and is a primary reason for seeking healthcare in Canada. The impact of OA in Canada is enormous and projected to cost Canada $17.5 billion annually in lost productivity alone by 2031. This study will use imaging and patient-reported Knee Outcomes Osteoarthritis Score (KOOS) to evaluate the incidence of OA at 10-years post ACL reconstruction with and without LET. We will also collect information about overall knee health, patient-reported outcomes, costs associated with knee injury, rehabilitation and disability, clinical failure, functional ability, and sport participation. It is crucial that we understand the risks of developing knee OA associated with the addition of an LET to an ACLR so that surgeons and patients can make informed decisions, not just for their immediate post injury treatment of the failed ligament, but for the potential long-term consequences of that decision.
Gender: All
Ages: 14 Years - 25 Years
Updated: 2025-03-20
4 states