Results of curative treatment

The results of a retrospective study are reported in two articles published on the site.

Cirotteau Y. The use of biocoral for hip fracture repair in elderly patients.
Bulletin de l'Institut Océanographique, Monaco 14 : 129-134. 1995

Patat JL, Cantaloube D, Cirotteau Y. Natural coral as bone graft substitute biomaterial ;
Corallo di ieri, corallo di oggi. Scienze e material i del patrimonio n, culturale.
Centro universitario europeo per i beni culturali. RAVELLO. 13-15 décembre1996. Bari : 2000.

A randomised prospective study was performed with the participation of ANVAR. It was approved by Nancy CCPPBR on 5 October 1999 as were the amendments of 7 December 2000 and 22 June 2001.

This study was set up by BIOCORAL Inc, following Dr Y. Cirotteau's work. On 26 November 1996, the company submitted an application to use the ACE-BGM procedure to evaluate granular coral samples to repair fractures in an osteoporotic environment. The study only began in December 1999. It has been spread over two years. 125 patients were included, split into four sections.

The coordinator is Prof. D. Mainard. Biomatech is acting as monitor. The Investigator Centres are: University hospitals at Rennes, Nîmes, Rouen, Nancy, Bordeaux, Strasbourg and Lyon, Neuilly and Neufchateau hospitals and Thionville regional hospital.

The preliminary results were as follows:

- There were 10 postoperative deaths: 4 using natural coral and 6 without coral.
- There were 5 serious orthopaedic complications without any casual relationship being established between the presence of natural coral and the occurrence of this serious adverse event.

The remaining patients are in postoperative follow-up. The average age is 84.6 with extremes of 65 and 101. Secondary deaths are therefore to be expected during the next year or years to come.

The clinical results, although preliminary and not yet validated statistically, are as follows:

- There is no particular morbidity linked to the use of natural coral at fracture sites in osteoporotic patients.
- No serious adverse event has been found to be linked to the procedure.
- The X-rays taken after several months show almost total resorption of the coral grains at the fracture site within one year.
- The return to a previous prefracture condition is observed to take place gradually, from the third month, which is quite remarkable given the average age of the patients included (84).
- In spite of the inherent difficulties in recruiting an elderly population of more or less dependent patients, follow-up has been extremely satisfying due to the motivation of the investigators taking part in the study.

During a second phase, the results of an objective analysis of X-rays will be provided by Prof. R. Duvauferrier and two senior radiologists as well as Dr JC Lambotte and two senior surgeons.
Biomatech is the operator appointed by the ANVAR.

The third phase will take place when all clinical results and X-rays have been analysed. An internationally recognised statistics centre will be in charge of producing the study report.