A prospective randomized controlled trial of a bioresorbable calcium phosphate paste (alpha-BSM) in treatment of displaced intra-articular calcaneal fractures.
BACKGROUND
Displaced intra-articular calcaneal fractures are devastating injuries and pose a therapeutic challenge. The purpose of this study was to determine whether open reduction internal fixation (ORIF) plus an injectable bioresorbable calcium phosphate paste (alpha-BSM [bone substitute material]) is superior to ORIF alone in the treatment of calcaneal bone voids encountered after operative treatment of displaced intra-articular calcaneal fractures.


METHODS
We prospectively randomized 47 patients with 52 closed displaced intra-articular fractures necessitating operative fixation to receive ORIF alone (n = 28) or ORIF plus alpha-BSM (n = 24). The maintenance of Böhler's angle was evaluated at follow-up visits for more than 1 year. Secondary outcome measures included the SF-36 and lower extremity measure every 6 months, and the Oral Analog Scale (OAS) score at 2 years.


RESULTS
There was no difference between the groups in the degree of collapse of Böhler's angle at 6 weeks and 3 months when compared with initial postoperative values. However, at 6 months, the mean collapse of the alpha-BSM and ORIF group was 5.6 degree (SD, 4.5 degree) and ORIF alone was 9.1 degree (SD, 5.8 degree), which was statistically significant (p = 0.03). Final radiographic evaluation after 1 year revealed a Böhler's angle loss of 6.2 degree (SD 5.9 degree) and 10.4 degree (SD 7.1 degree) in alpha-BSM and ORIF and ORIF alone groups, respectively, (p = 0.05). There was no difference between the two groups in regards to secondary outcome measures of general health, limb specific function, and pain past 2 years.


CONCLUSIONS
These results support the use of an injectable, in situ hardening calcium phosphate paste to fill the bone void after a displaced intra-articular calcaneal fracture. There was no impact on general health, limb specific function, and pain past 2 years and no associated complications with alpha-BSM use, supporting it safety as an augment to ORIF.
Johal
Herman S
HS
Department of Orthopaedic Surgery, Foothills Medical Centre, University of Calgary, Calgary, Alberta.
Buckley
Richard E
RE
Le
Ian L D
IL
Leighton
Ross K
RK
D000293:Adolescent; D000328:Adult; D000368:Aged; D018786:Bone Substitutes / Q000008:administration & dosage*; D002111:Calcaneus / Q000000981:diagnostic imaging / Q000293:injuries*; D002130:Calcium Phosphates / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005260:Female; D005593:Fracture Fixation, Internal; D050723:Fractures, Bone / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D006305:Health Status Indicators; D006801:Humans; D007270:Injections, Intra-Articular; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D055815:Young Adult
D018786:Bone Substitutes; D002130:Calcium Phosphates; C020243:calcium phosphate