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 Overview

• Status: Terminated
• Conditions: Pes Planovalgus
• Intervention / Treatment: Device: ReproBone; Procedure: calcaneal lengthening

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReproBone; calcaneal lengthening	Device: ReproBone; Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy; Other Names: 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 Names: Autologous bone graft
Active Comparator: Autologous bone graft; calcaneal lengthening	Procedure: calcaneal lengthening; Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy; Other Names: Autologous bone graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiostereometric Analysis (RSA) of the calcaneal lengthening osteotomy	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.	Postoperative, 6 weeks, 8 weeks, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Pain	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.	The first 24 hrs after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pedobarography	Pedobarography: The investigators use a pressure plate from Tekscan. The pressure of the patients feet is measures during stance and walking.	preoperative, 6 months, 12 months
OxAFQ	health related quality of life in children with foot/ankle issues	preoperative, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Ceramisys Ltd
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 10, 2016

Study Registration Dates

• First Submitted: September 26, 2012
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: calcaneal lengthening; calcium ceramics; noninferiority; radiostereometric analysis
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 1-10-72-250-12; Interventional (Oncolys BioPharma Inc)