OUS Clinical Sites
Three clinical sites are currently enrolling outside of the United States under WIRB data collection protocol. To find out more about eligibility for these studies, please visit the practice sites below.
INDICATIONS
The BalancedBack Total Joint Replacement is indicated for disorders requiring nerve decompression, restabilization, and maintenance of or improvement in sagittal balance. The subject has a primary diagnosis of lumbar degeneration (e.g. HNP, central disc herniation, annular tear) with or without facet degeneration with or without stenosis of the lumbar spine from L1 to S1 confirmed by subject history (e.g. leg and/or back pain or symptoms in the sciatic nerve distribution) and radiographic studies (e.g. MRI and plain radiographs) with no more than a Grade I Spondylolisthesis (< 3mm).
Cayman Spine
Grand Cayman
Cayman Spine is enrolling single and multilevel BalancedBack patients at Doctors Hospital in Grand Cayman.
Spine Africa
Pretoria
Dr Louis Nel is enrolling single and multilevel BalancedBack patients at Zuid-Afrikaans Hospital in Pretoria, South Africa.
University of Cape Town
Cape Town
Dr Robert Dunn is enrolling single and multilevel BalancedBack patients at the University of Cape Town in Cape Town, South Africa.
About 3Spine
3Spine is a new kind of healthcare company that vertically integrates the development, clinical research, and delivery of novel healthcare technologies. The BalancedBack Total Joint Replacement is the first technology platform developed by 3Spine as an alternative to fusion for the lumbar spine.
3Spine SEZC
Cayman Enterprise City
The Strathvale House, 4th floor
90 N Church Street
George Town, Grand Cayman
Cayman Islands
1-345-232-0690
3Spine Management Co. Inc
46 Railroad Ave
Unit 204
Duxbury, MA 02332
1-781-291-8040
Disclaimer
The BalancedBack procedure is not available in the United States. The information within BalancedBack.com is not intended as a substitute for medical professional help or advice. Statements made on this site are not to be interpreted as a guarantee.