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A non-inferiority study to demonstrate efficacy of the HAVAI minimally invasive device compared to standard of surgical care 1st metatarsal osteotomy (SSOC)
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Inclusion criteria
Exclusion criteria
Patients who need or may need to have 2nd MT osteotomy as part of their index surgery (e.g. instability or subluxation of 2nd MTPJ)
History of:
a. Severe Diabetes mellitus (defined as existence of: i. More than 10 years duration ii. HbA1C 8.0 < iii. any known complications of diabetes (PVD, Nephropathy [CR>1.3], retinopathy, IHD)) b. Claudication, known peripheral vascular disease or no palpable pulses (DP or TP).
c. Known rheumatoid or inflammatory disease. d. X-ray evidence of moderate osteoarthritis of MTPJ-1 or TMTJ-1. e. neurological conditions associated with spasticity or lower limb paralysis. f. Prior operation on MT1 or MT2. g. Fracture (past or present) of MT1 or MT2.
Aseptic necrosis or any deformity of MT2 head.
Aseptic necrosis of the MT1 head
Pregnant women or women with childbearing potential who are not obliged to take any contraception measures
Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
ASA grade above 2
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Ayelet Goldwasser, CTA; Daniel Billig, MBA
Data sourced from clinicaltrials.gov
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