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

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ClinicalTrials.gov Identifier: NCT01770574
Recruitment Status : Terminated (Interim results showed that the HATCP material was not non-inferior to the AUTO graft.)
First Posted : January 18, 2013
Last Update Posted : August 9, 2016
Sponsor:
Collaborator:
Ceramisys Ltd
Information provided by (Responsible Party):
University of Aarhus

September 26, 2012
January 18, 2013
August 9, 2016
February 2013
December 2016   (Final data collection date for primary outcome measure)
Radiostereometric Analysis (RSA) [ Time Frame: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months ]
RSA examinations will be performed at baseline (first/second postoperative day), after 6 weeks, 8 weeks, 6 months and 12 months. Aim: To assess stability of the osteotomy and any micro motion in the neighbouring calcaneal-cuboid joint.
Visual Analog Scale [ Time Frame: 12 hrs ]
The pain will be assessed within the first 24 hrs
Complete list of historical versions of study NCT01770574 on ClinicalTrials.gov Archive Site
Pain [ Time Frame: The first 24 hrs after surgery ]
Pain will be assessed as general pain, by VAS/NRS/faces scaling at baseline (pre-op), 3 hrs, 5 hrs, 8 hrs, 12 hrs after surgery. Although minor changes in the specific time points can occur if the child is sleeping, since it would be unethical to wake them up.
Radiographic stereometric assay (RSA) [ Time Frame: The RSA will be taken at baseline and the final investigation at 12 months ]
RSA wille be taken immediately postoperative, after 6 weeks, after 8 weeks, after 6 months and after 12 months. In this way the investigators will evaluate the healing progress and be able to assess eventual microluxation in the cuboideum relatively to calcaneus.
  • Pedobarography [ Time Frame: preoperative, 6 months, 12 months ]
    Pedobarography: The investigators use a pressure plate from Tekscan. The pressure of the patients feet is measures during stance and walking.
  • OxAFQ [ Time Frame: preoperative, 6 months, 12 months ]
    health related quality of life in children with foot/ankle issues
Pedobarography [ Time Frame: preoperative, 6 months, 12 months ]
Preoperative: The ambulatory examination prior to surgery. Pedobarography: The investigators use a pressure plate from Tekscan. The pressure of the patients feet is measures during stance and walking.
 
New Bone Grafting Technique in Paediatric Foot Surgery. Validation of Outcome Measures
Structural HATCP Graft vs Tricortical Iliac Crest Autograft in Paediatric Calcaneal Lengthening Osteotomies: Interim Results From a Randomised Controlled Noninferiority Study

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).

Study C: HA-β TCP (ReproBone™) vs. autologous tricortical iliac crest bone graft in a calcaneal lengthening osteotomy in children with pes planovalgus. A clinical randomized controlled non-inferiority study with 12 months of follow-up.

Purpose. To investigate the clinical and radiographic findings of a calcaneal lengthening osteotomy by comparing autologous bonegraft and HA-β-TCP graft in a group of children with hindfoot valgus deformities. The primary outcome measure the stability of the osteotomy measured by migrations in the x-translation by RSA.

Design. Prospective, randomized controlled non-inferiority study.

Randomization: Children who fulfill the criteria for inclusion together with their parents/guardian receive information about the project. The patients are randomized to respectively HA-ß-TCP and iliac crest bone graft.

Surgical procedure: Calcaneal lengthening osteotomy is performed between the anterior and middle facet of the subtalar joint. The corticalis of the calcaneus is bilaterally cut through. The planovalgus deformity is corrected and with a graft matching the wedged osteotomy is inserted. Tantalum balls are inserted into calcaneus on each side of the osteotomy and in cuboideum. Postoperative pain treatment consist of a tibial nerve catheter which is used the first 24 hours. Patients in whom graft is harvested from the iliac crest get local infiltration analgesics accordingly to a standardized procedure. The pain is registered by the use of a visual analog scale (VAS, NRS, faces scale) a 3, 8 and 12 hours postoperative. The amounts of used analgesics are registered. The stability of the osteotomy is assessed by radiostereometric assay (RSA) at the following time points: Baseline (first/second postoperative day) after 6 weeks, 8 weeks, 6 months and 12 months.

Power and significance: The primary parameter is stability of the osteotomy, measured as x-translations by the RSA software. We used continuous non-inferiority sample size calculations. With alpha 0.05 and power 0.9, non-inferiority limit 2 mm and sd 1.5 mm we estimated the sample size to 10 patients in each group. To secure against drop-out, we plan to include 15 patients in each group.

For ethical considerations an interim analysis was planned when 10 patients completed 6 months RSA follow-up. Primary outcome was compression of the osteotomy. We used a 99.8% confidence interval.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pes Planovalgus
  • Device: ReproBone
    Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy
    Other Name: Hydroxy-apatite-tricalcium-phosphate
  • Procedure: calcaneal lengthening
    Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
    Other Name: Autologous bone graft
  • Experimental: ReproBone
    calcaneal lengthening
    Interventions:
    • Device: ReproBone
    • Procedure: calcaneal lengthening
  • Active Comparator: Autologous bone graft
    calcaneal lengthening
    Intervention: Procedure: calcaneal lengthening
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
30
December 2016
December 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
5 Years to 16 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01770574
1-10-72-250-12
Interventional ( Other Identifier: Videnskabsetisk Komité )
No
Not Provided
Not Provided
University of Aarhus
University of Aarhus
Ceramisys Ltd
Study Director: Bjarne Møller-Madsen, DMSc, Prof Department of Children's Orthopaedics Aarhus University Hospital
Principal Investigator: Polina Martinkevich, PhD-student Department of Children's Orthopaedics Aarhus University Hospital
Study Chair: Ole Rahbek, Assoc prof PhD MD Department of Children's Orthopaedics, Aarhus University Hospital
Study Chair: Martin Gottliebsen, MD PhD-stud Department of Children's Orthopaedics, Aarhus University Hospital
Study Chair: Maiken Stilling, MD, PhD Department of Orthopaedics, Aarhus University Hospital
Study Chair: Line Kjeldgaard Pedersen, MD, PhD Department of Children's Orthopaedics, Aarhus University Hospital
University of Aarhus
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP