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ACTIVE NOT RECRUITING

NCT05570760

Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy

Sponsor: Biomendex Oy

View on ClinicalTrials.gov

Summary

The aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery. The study intervention is medial open wedge high tibial osteotomy (OWHTO) with loadbearing plate fixation, where a bone graft substitute material Adaptos®Ortho Wedge is evaluated when used as a bone void filler. Investigational device is expected to support bone formation in osteotomy gap and to resorb in the body. The comparator arms are treated with medial OWHTO with plate fixation, either without a bone graft (the bone defect is left empty, non-augmented osteotomy) or by using a comparator product (chronOS® Wedge, semi-circular) as a bone void filler.

Official title: Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy: A Randomized, Controlled, Partially Blinded, Multi-Center Trial.

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-04-08

Completion Date

2027-12

Last Updated

2025-08-20

Healthy Volunteers

Conditions

Knee Deformity

Interventions

DEVICE

Adaptos®Ortho Wedge (bone grafting surgery)

After screening and enrollment, subjects will undergo medial knee open wedge high tibial osteotomy (OWHTO) with load bearing locking plate fixation. A synthetic bone graft will be used as a bone void filler in the osteotomy defect. Follow-up visits will be at 6 weeks, 3 months, 6 months, and 12 months.

PROCEDURE

OWHTO without bone grafting

After screening and enrollment, subjects will undergo medial knee open wedge high tibial osteotomy (OWHTO) with load bearing locking plate fixation, without bone grafting. Follow-up visits will be at 6 weeks, 3 months, 6 months, and 12 months.

DEVICE

chronOS® Wedge (bone grafting surgery)

Inclusion Criteria: * Subjects aged between 25 and 65 years at the time of enrolment. * Subjects that sign and date a written, informed consent form (ICF) prior to the initiations of any trial procedures, after the nature of the trial has been explained according to regulatory requirements. * Subjects who can comply with trial procedures and are available for the duration of the trial. * Accepts all treatment arms. * Subjects with varus malalignment of the knee, scheduled to have medial open-wedge high tibial osteotomy (OWHTO) but are otherwise in good health at the time of entry into the trial as determined by medical history, physical/clinical examination, and clinical 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 on the weight-bearing x-ray of the full leg in AP view using Miniaci Method. * Body Mass Index (BMI) ≤30 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 operation area, clinically relevant, not medically managed, severe acute or chronic medical illness, immune-compromised, metabolic/systemic bone disorder, untreated malignant myeloma, Burkitt's lymphoma, lateral osteoarthritis (Kellgren-Lawrence grade \>1) * Smoking or use of other nicotine products * 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 would preclude reliable assessment. * Women who are pregnant or breast feeding or planning to become pregnant during the study. * Any use of calcitonin, bisphosphonates or recombinant PTH 1-34, 1-84 or other PTH fragments/analogues 6 months prior to surgery or during the study (12 months po). * Enrolment of the investigator, his/her family members, employees, and other dependent persons. * Involved in study of another investigational product that may affect outcome.

Locations (6)

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Meilahti Bridge Hospital, Helsinki University Hospital

Helsinki, Finland

Pihlajalinna Kelloportti

Tampere, Finland

Petz Aladár University Teaching Hospital

Győr, Hungary

University of Szeged Szent-Györgyi Albert Clinical Center

Szeged, Hungary

Szent György University Teaching Hospital

Székesfehérvár, Hungary