[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586183":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":20,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":20,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Vestre Viken Hospital Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tendon Achilles Lengthening using needle technique","ACTIVE_COMPARATOR","The arm in question involves the administration of a specific intervention via a precise needle technique, as outlined in the study protocol. The needle technique employed ensures optimal delivery of the intervention, ensuring safety and efficacy for the patient population under investigation. Further details regarding the needle technique are described in the full protocol.",[13],"Procedure: Needle tendon lengthening technique",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Needle tendon lengthening technique","Percutaneous Achilles tendon lengthening with the needle technique is performed by applying a series of microtenotomies to the tendon using needle pricks while the tendon is stretched. A withdrawal needle with a diameter of 1.1-1.2 mm is used. The needle pricks gradually weaken the tendon and stretch it to the desired length without opening the skin or tendon sheath. As a rule, it is desirable to achieve approximately 10-15 degrees of dorsiflexion before concluding the lengthening.\n\nLocal infiltration anesthesia is applied, followed by a simple bandage. The surgical procedure typically takes 3-4 minutes. Finally, a boot cast in soft plaster with the foot and ankle in neutral position is applied, and it can be fully weight-bearing immediately.\n\nThe cast is removed at the clinic after 4 weeks. After cast removal, the child\u002Fadolescent should be allowed gentle activity - not sports - for another 4 weeks, thereafter unrestricted activity.\n\nPhysical therapy may be utilized as needed, locally.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Per Reidar Høiness, MD Phd","CONTACT","+47 975 27 911","prhoines@vestreviken.no",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Drammen Sykehus, Vestre Viken HF","RECRUITING","Drammen","3004","Norway","NO",{"type":36,"coordinates":37},"Point",[38,39],10.20449,59.74389,{"lat":39,"lon":38},[42,43],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":23,"role":44,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100586183","a-needle-technique-for-achilles-tendon-lengthening-in-pediatric-patients-a-prospective-study-on-efficacy-safety-and-feasibility-100586183",false,"NCT06912061","A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility","Inclusion Criteria:\n\n* Age: 5-16 years\n* Consent from parents\u002Fguardians\n* Indication for Achilles tendon lengthening (toe walking, spasticity), both unilateral and bilateral:\n* Equinus foot with dorsiflexion ≤ 0 degrees with the knee extended and the heel in neutral position.\n* Symptomatic equinus foot, meaning a foot position causing pain, discomfort, increased fatigue, etc.\n\nExclusion Criteria:\n\n* Unwillingness to participate, lack of consent\n* Previous surgical Achilles tendon lengthening, e.g., for clubfoot\n* Received BoNT-a injection in the triceps surae within the last 6 months\n* Contracture in the ankle joint, i.e., equinus position not due to a tight Achilles tendon\n* Positive Silfverskiöld test and dorsiflexion \\> 5 degrees with the knee extended (indicating the need for gastrocnemius recession)\n* Concurrent other surgery\u002Fother procedures on the same lower extremity, including BoNT-a injection","ALL","5 Years","16 Years",{"count":57,"type":58},50,"ESTIMATED","INTERVENTIONAL",[61],"NA","For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length. So far, no negative effects, complications or tendon problems have been observed. A prospective study of a cohort of children and adolescents is planned where there is an indication for Achilles lengthening, such as spastic or non-spastic contracture and toe walking that results in an unwanted shortening of the Achilles tendon that makes walking difficult. We plan to include up to 50 children and adolescents over a two-year period and follow them closely for the first year after surgery. Pediatric physiotherapists will perform all clinical examinations to limit observer bias, and a radiologist will examine the tendon tissue with ultrasound before and one year after surgery to check anatomical conditions. The study will examine safety, effectiveness and feasibility of using the method, and anatomy, patient satisfaction and quality of life.",[64],"Equinus Contracture",[66,67,68],"Idiopathic toe walking (ITW)","Tendon Achilles Lengthening (TAL)","needle technique","2025-04-09",{"date":71,"type":72},"2025-04-13","ACTUAL",{"date":74,"type":72},"2025-01-01",{"date":76,"type":58},"2027-08-31",{"name":5,"class":6},1]