TerminatedNot Applicable

New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures

Stopped: Interim results showed that the HATCP material was not non-inferior to the AUTO graft.

Denmark12 participantsStarted 2013-02

Plain-language summary

The purpose of this study is to determine whether structural calcium ceramic bone graft substitute (ReproBone™) is non-inferior compared to autologous tricortical iliac crest bone graft in lateral calcaneal lengthening osteotomies in pediatric patients and reduces postoperative pain. To groups of patients (age 5-16) will be compared. One group randomized to autologous bone graft and the other group randomized to calcium ceramic. The evaluation will be based on radiostereometric analysis, pedobarography, Patient reported outcome assessment (Oxford Ankle Foot Questionnaire), and pain (measured by visual analog scale and numerical range scale).

Who can participate

Age range5 Years – 16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged between 5-16 years with symptomatic planovalgus deformity admitted to the Department of Children's Orthopaedics, Aarhus University Hospital during the period 2012 to 2016. The surgical procedure is performed in about 10 children a year. Pain and/or callosities. Informed written consent from the child custody/guardianship. Ambulatory function No severe cognitive deficits Exclusion Criteria: Reoperation will exclude patients from further follow-up

What they're measuring

Radiostereometric Analysis (RSA) of the calcaneal lengthening osteotomy

Timeframe: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months

Trial details

NCT IDNCT01770574

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-12-01

View on ClinicalTrials.gov More Pes Planovalgus trials