Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Interim results showed that the HATCP material was not non-inferior to the AUTO graft.)
Sponsor:
Collaborator:
Ceramisys
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01770574
First received: September 26, 2012
Last updated: August 8, 2016
Last verified: July 2016
  Purpose

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).


Condition Intervention
Pes Planovalgus
Device: ReproBone
Procedure: calcaneal lengthening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structural HATCP Graft vs Tricortical Iliac Crest Autograft in Paediatric Calcaneal Lengthening Osteotomies: Interim Results From a Randomised Controlled Noninferiority Study

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Radiostereometric Analysis (RSA) [ Time Frame: Postoperative, 6 weeks, 8 weeks, 6 months, 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Pain [ Time Frame: The first 24 hrs after surgery ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Pedobarography [ Time Frame: preoperative, 6 months, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    health related quality of life in children with foot/ankle issues


Enrollment: 12
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ReproBone
calcaneal lengthening
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
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 Name: Autologous bone graft

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.

  Eligibility

Ages Eligible for Study:   5 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770574

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Ceramisys
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
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01770574     History of Changes
Other Study ID Numbers: 1-10-72-250-12  Interventional 
Study First Received: September 26, 2012
Last Updated: August 8, 2016
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
calcaneal lengthening
calcium ceramics
noninferiority
radiostereometric analysis

Additional relevant MeSH terms:
Flatfoot
Foot Deformities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on December 02, 2016