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NCT07130357
This prospective multicenter randomized controlled trial evaluates the clinical efficacy of collagen scaffold augmentation in surgical repair for acute Achilles tendon ruptures. The study will enroll 48 adult participants randomly assigned to either the intervention group (surgical repair with collagen scaffold augmentation) or the control group (standard surgical repair without scaffold). The primary outcome is tendon function assessed using the VISA-A score, while secondary outcomes include tendon healing characteristics measured by ultrasound (thickness, neovascularity), calf muscle strength, ankle range of motion, and complication rates. Follow-up assessments will be conducted at 6 weeks, 3 months, 6 months, and 12 months post-surgery. The study aims to determine whether collagen scaffold augmentation enhances tendon healing and functional recovery compared to conventional repair methods, potentially offering a improved treatment approach for Achilles tendon injuries.
NCT06723639
The goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation . We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.
NCT03259204
Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments. This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.
NCT02318472
The purpose of this study is to determine whether early mobilization after Achilles tendon rupture can speed up healing, prevent development of venous thromboembolism and improve patient outcome.
NCT03525314
The objective of this study is to examine how elongation of the Achilles tendon develops during the first year after rupture among patients with an Achilles tendon rupture, and how it affects physical function. The aim is to define a cutoff of acceptable elongation dividing the patients who obtain normal physical function (Limb Symmetry Index \> 90%) from those who do not. Patients treated both operatively and non-operatively will be included.
NCT02015364
Study objectives To investigate if early controlled mobilization of the ankle in week 3 to 8 affects the functional outcome and patient reported outcome after treatment of acute Achilles tendon rupture. Type of study Randomized, controlled trial (RCT). 130 patients will be included. Time schedule Begins January 2014. Study period is 4-5 years; recruitment is expected to span 2 years Setup At Copenhagen University Hospital Hvidovre the majority of patients with acute ATR are treated non-operatively. A cast is applied in the emergency room. After 2 weeks the bandage is changed to a removable orthosis and full weight bearing is allowed. Patients who choose to participate in the trial will - through randomisation - be placed in one of the two groups: 1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3. 2. The control group: In line with the current treatment regimen the patients must keep the boot on at all times and they are not allowed to move the ankle. Treatment protocol for the two groups is similar concerning orthose, removal of wedges and weight-bearing. The only difference is that patients in the intervention group are instructed to do ankle exercise. Post-examinations in relation to the study Follow-up is done at 8 and 16 weeks plus 6 and 12 months. The study's primary endpoint is at the 12 month mark. Population Patients who are treated for acute Achilles tendon rupture at Copenhagen University Hospital Hvidovre. Patients who fulfil the inclusion criteria but do not wish to participate are treated according the standard regimen (non-operatively without early controlled movement of the ankle joint). Number of patients 65 patients will be included in each group (a 130 patients in total).
NCT01833936
Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing. The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.
NCT01470833
Acute achilles tendon rupture is relatively frequent (11 to 37 per 100,000). There are great social benefits in optimizing treatment and shortening recovery. There is no consensus concerning the best treatment of acute achilles tendon rupture. Traditionally, surgical treatment is considered superior, but more recent studies show evidence that non-operative treatment with early dynamic rehabilitation gives the same functional outcome with fewer side effects. Traditionally non-operative treatment involves non-weightbearing for 6 weeks. This is not evidence based rather due to tradition. It is well documented that mechanical load improves tendon healing in general and has no detrimental effect on the healing of operated achilles tendons. The objective of this randomized study is to compare early weight-bearing with non-weight-bearing following non-operative treatment of acutely ruptured Achilles tendons.
NCT01778816
Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments. Comparing force torque measurements, muscle volume and clinical scores.
NCT01265004
This project investigates microcirculation in skin and tendon after a rupture of the Achilles tendon. Three different treatments are compared: stitches of the tendon, fibrin-glue and the combination of both.