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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.
NCT06639308
* A well-established protocol for the treatment or augmentation a wide range of Achilles disorders including chronic Achilles tendon (AT) rupture, Achilles insertional tendinopathy, Haglund syndrome and among others, is a Flexor hallucis longus (FHL) tendon transfer (1-4). * Long incisions are required for open surgical procedures, which increase the risk of skin breakdown and wound infection. These factors have contributed to the increased use of endoscopy in the surgical treatment of different Achilles pathologies. Compared to open methods, endoscopic techniques provided the advantage of managing pathology with a low risk of soft-tissue complications(4-7). * It has been recommended to use an FHL transfer. (8-10) Its anatomic proximity prevents iatrogenic lesions of the neurovascular bundle, it fires in phase with the gastrocnemius-soleus complex, it is a stronger plantar flexor, and its axis of contractile force more closely looks similar to that of the AT. It is plantar flexion strength reinforcement, which is almost always compromised with fascial advancement alone(11). Regarding the nature of the AT's vascularization, the FHL muscle belly reaches distally into its avascular zone, which allows the repaired AT to be recruitment of an increased blood supply. Moreover, by moving muscles that perform the same function, FHL transfer preserves the ankle's natural muscular balance. (8) A recent study using magnetic resonance imaging evaluation revealed that in 60% of patients, the FHL tendon had fully integrated, and in 80% of patients, there was hypertrophy of the tendon above 15%. * This study tends to compare the outcomes of both open and endoscopic FHL transfer in different parameters like functional outcome, wound complication, and accelerated rehabilitation. * This is a Prospective, randomized control trial. The study will be conducted on 30 patients complaining of chronic Achilles tendon rupture, Achilles insertional tendinopathy, Haglund syndrome planned for FHL transfer in Assiut university hospital. Patients will be randomized to two groups one group endoscopic FHL will be conducted in other hand second group open FHL will be conducted. The PICOT algorithm was preliminarily pointed out: * P (Problem): Different Achilles disorders such as chronic Achilles tendon (AT) rupture, Achilles insertional tendinopathy, Haglund syndrome and among others. * I (Intervention): Endoscopic FHL Transfer. * C (Comparison): open FHL tendon transfers. * O (Outcomes): Clinical outcomes, complications, and return to sport. * T (Timing): ≥6 months of follow-up. Preoperative assessment: A- Detailed history and examination: * Detailed history for patient complains and previous trauma or surgery. * Physical examination for FHL, AT, any foot and ankle deformities, functional Achilles pathology or ankle range-of-motion deficits. * VAS score, Achilles tendon Total Rupture Score - ATRS, American Orthopaedic Foot \& Ankle Society (AOFAS) hindfoot score and ankle plantarflexion strength will be assessed preoperatively and at the latest follow-up (minimum of 1 year after the procedure). Research outcome measures: a. Primary (main): Functional outcome of endoscopic versus open FHL transfer in various TA pathology (American Orthopaedic Foot \& Ankle Society (AOFAS) ankle-hindfoot score), Achilles tendon Total Rupture Score - ATRS, ankle plantarflexion strength. .Secondary (subsidiary): * Wound complication, skin dehiscence and infection rate. * Expected time to complete return to sports activities or return to previous levels of activity. * Accelerated 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.
NCT03704532
A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.
NCT06112288
Achilles tendon rupture is common among physically active individuals. Limitations, decreases in the level of standing on heel rise, and due to these limitations, failures in functional activities such as returning to sports, walking, running, jumping and performance tests are observed. Manual therapy methods included in rehabilitation programs are an effective option in solving these problems. The aim of the study is to investigate the effects of Compressive Myofascial Release and Ankle joint mobilization on ankle joint movement, functional tests, elasticity and stiffness of the muscle-tendon complex and muscle tone parameters in individuals who underwent Achilles tendon repair.
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.
NCT03931486
The etiology and pathogenesis of acute Achilles tendon ruptures are complex and not fully understood. It is well known that they are associated with pre-existing pathological alterations, similar to the changes observed in tendinopathy. The present study investigates if bacteria and collagen metabolism play a role in the etiology of acute Achilles tendon rupture. During surgery, 20 patients will have taken two biopsies from the ruptured part of the tendon and two biopsies from the healthy tissue of the same tendon 2-4 cm proximal to the rupture, as a control.
NCT04962243
To explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism.
NCT04663542
This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.
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).
NCT02012803
The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months. Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.
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.
NCT00284648
This study is intended to determine whether the optimal treatment of acute Achilles tendon ruptures is surgical repair or functional bracing. Our hypotheses are surgical repair will: 1) Result in a clinically relevant decrease in re-rupture rate and 2) Result in a clinically relevant improvement in disease specific quality of life and 3) A clinically relevant improvement in functional outcome measures
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.
NCT00537784
People operated for a rupture of the Achilles tendon receive a concentrate of their own platelets injected into the operated area. The study is randomized and single-blinded, with 20 treated patients and 20 controls, who get no injection. The primary endpoint is a mechanical property of the tendon after 12 weeks (modulus of elasticity), as measured by a special type of radiography. This radiography uses 0.8 mm metal markers, which are injected into the tendon. The tendon is mechanically loaded during radiography and its strain can be measured as increased distance between the markers. Other mechanical variables at 6, 12 and 52 weeks are secondary variables, as well as a validated patient-administrated questionaire at 1 year.
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.
NCT00489749
The purpose of this study was to determine the effect of protected early weightbearing (PEWB) compared to non-weightbearing (NWB) after surgery for an Achilles tendon rupture (ATR) on health related quality of life (HRQL) in the initial six week period after surgery, functional recovery over time, return to work and activity and complications. We hypothesized that PEWB following ATR repair would result in: i) improved HRQL in the initial postoperative period, ii), a quicker recovery of HRQL, strength and endurance, iii) earlier return to work and sport, and iv) no increase in complications, such as re-rupture compared to NWB.