Is structural hydroxyapatite tricalcium-phosphate graft or tricortical iliac crest autograft better for calcaneal lengthening osteotomy in childhood? interim results from a randomised, controlled non-inferiority study.
OBJECTIVE
To compare the structural durability of hydroxyapatite-tricalcium phosphate (HATCP) to autologous iliac crest bone graft in calcaneal lengthening osteotomy (CLO) for pes planovalgus in childhood.


METHODS
We present the interim results of ten patients (HATCP, n = 6 and autograft, n = 5) with a mean age of 11.5 years (8.2 to 14.2) from a randomised controlled non-inferiority trial with six months follow-up. The primary outcome was the stability of the osteotomy as measured by radiostereometric analysis. A non-inferiority margin of ≤ 2 mm osteotomy compression was set.


RESULTS
At six months the data showed that the osteotomy had been compressed by a mean 1.97 mm (99.8% confidence interval -1.65 to 5.60) more in the HATCP group than in the autograft group. Migration of the CLO grafted with HATCP stabilised at six months rather than at six weeks with autograft.


CONCLUSIONS
This is the first randomised trial to compare the efficacy of HATCP graft with autograft in terms of stability of CLO in children. Because of problems with the HATCP the trial was stopped. We do not recommend HATCP graft in its current structure for use in unfixed CLOs. Cite this article: Bone Joint J 2016;98-B:1554-62.
Aarhus University Hospital, Nørrebrograde 44, 8000 Aarhus C, Denmark.
P
P
Martinkevich
Aarhus University Hospital, Nørrebrograde 44, 8000 Aarhus C, Denmark.
O
O
Rahbek
Aarhus University , Palle Juul-Jensens Boulevard 82, 8200 Aarhus N, Denmark.
M
M
Stilling
Aarhus University Hospital, Nørrebrograde 44, 8000 Aarhus C, Denmark.
L K
LK
Pedersen
Aarhus University Hospital, Nørrebrograde 44, 8000 Aarhus C, Denmark.
M
M
Gottliebsen
Aarhus University Hospital , Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.
K
K
Søballe
Aarhus University Hospital, Nørrebrograde 44, 8000 Aarhus C, Denmark.
B
B
Møller-Madsen
D000293:Adolescent; D001852:Bone Lengthening / Q000009:adverse effects / Q000379:methods; D018786:Bone Substitutes / Q000009:adverse effects / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000379:methods; D002111:Calcaneus / Q000601:surgery; D002648:Child; D002675:Child, Preschool; D005260:Female; D005413:Flatfoot / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D006882:Hydroxyapatites / Q000009:adverse effects / Q000627:therapeutic use*; D007085:Ilium / Q000637:transplantation*; D008297:Male; D010027:Osteotomy / Q000009:adverse effects / Q000379:methods*; D010149:Postoperative Pain; D059869:Radiostereometric Analysis / Q000379:methods; D016896:Treatment Outcome
D018786:Bone Substitutes; D006882:Hydroxyapatites; C074950:hydroxyapatite-beta tricalcium phosphate
Autograft; Calcaneal lengthening; Planovalgus; Radiostereomteric analysis; Tricalciumphosphate hydroxyapatite; randomised controlled trial