Phase
Condition
Holoprosencephaly
Birth Defects
Treatment
chronOS® Wedge (bone grafting surgery)
Adaptos®Ortho Wedge (bone grafting surgery)
OWHTO without bone grafting
Clinical Study ID
Ages 25-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects aged between 25 and 60 years at the time of enrolment.
Subjects that sign and date a written, informed consent form (ICF) prior to theinitiations of any trial procedures, after the nature of the trial has beenexplained according to regulatory requirements.
Subjects who can comply with trial procedures and are available for the duration ofthe trial.
Accepts all treatment arms.
Subjects with varus malalignment of the knee, scheduled to have medial open-wedgehigh tibial osteotomy (OWHTO) but are otherwise in good health at the time of entryinto the trial as determined by medical history, physical/clinical examination, andclinical judgement of the investigator.
Full knee range of motion (ROM) (at least 5-120 degrees).
Preoperatively planned osteotomy 5-13 degrees of the proximal tibia done based onthe weight-bearing x-ray of the full leg in AP view using Miniaci Method.
Body Mass Index (BMI) ≤30
Exclusion
Exclusion Criteria:
Previous knee area osteotomy or lower limb arthroplasty of the investigational knee.
Presence of the following unfavourable conditions: osteoporosis,infectious/inflammatory joint disease, infections, or inflammation in the operationarea, clinically relevant, not medically managed, severe acute or chronic medicalillness, immune-compromised, metabolic/systemic bone disorder, untreated malignantmyeloma, Burkitt's lymphoma, lateral osteoarthritis (Kellgren-Lawrence grade >1)
Smoking
Inability to follow the procedures of the study, e.g. due to language problems,dementia, psychiatric disorder or behaviour etc. of the participant
Recent history of substance abuse (ie, recreational drugs, alcohol) that wouldpreclude reliable assessment.
Women who are pregnant or breast feeding or planning to become pregnant during thestudy.
Any use of estrogens, estrogen-progestin therapy, or selective estrogens receptormodulators (SERMs) 3 months prior to and after the surgery.
Any use of calcitonin, bisphosphonates or recombinant PTH 1-34, 1-84 or other PTHfragments/analogues 6 months prior to surgery or during the study (12 months po).
Enrolment of the investigator, his/her family members, employees, and otherdependent persons.
Involved in study of another investigational product that may affect outcome.
Study Design
Study Description
Connect with a study center
Meilahti Bridge Hospital, Helsinki University Hospital
Helsinki,
FinlandActive - Recruiting
Töölö Hospital, Helsinki University Hospital
Helsinki,
FinlandSite Not Available
Oulu University Hospital
Oulu,
FinlandSite Not Available
Pihlajalinna Kelloportti
Tampere,
FinlandActive - Recruiting
Pihlajalinna Koskisairaala
Tampere,
FinlandSite Not Available
Turku University Hospital / Tyks Surgical Hospital
Turku,
FinlandSite Not Available
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