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

NCT05570760 | Active Not Recruiting DMC

• 1 other identifier: AdaptosOrtho-001
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 6

Brief 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.

Conditions

Knee Deformity

Keywords

synthetic bone graft; Adaptos; high tibial osteotomy; orthopaedics

Outcome Measures

Primary Outcomes (1)

• Radiographic bone regeneration of the osteotomy defect, comparison between three treatment arms.

  Radiographic bone regeneration assessments of the native x-ray of the standing anteroposterior (AP) radiographs of the knee, evaluated in the mediolaterally divided five zones of the osteotomized gap area (Brosset 2011), with rating of six bone remodeling phases (phases 0-5, with the score of 5 for the best outcome).The primary endpoint is the sum of the remodeling phase scores (0-5) in each of the five zones of the osteotomized gap area (range 0-25). Assessment longitudinally at 6-weeks and repeatedly at 3-, 6-, and 12-months post-surgery. Primary evaluation is done 12 months after surgery.

  Change from baseline to 12 months.

Other Outcomes (11)

• Bone union of the tibial posterior cortex

  Change from baseline to 12 months.

• Questionnaire: KOOS (Knee Injury and Osteoarthritis Outcome Score)

  Change of KOOS score from baseline to 12 months.

• Questionnaire: FJS (Forgotten Joint Score)

  Change from baseline to 12 months.

Study Arms (3)

Adaptos®Ortho Wedge

EXPERIMENTAL

Bone augmentation after Open Wedge High Tibial Osteotomy (OWHTO), with Adaptos®Ortho Wedge (Biomendex Oy, synthetic bone graft material) in combination with a load bearing TomoFix® Medial High Tibia Plate (DePuy Synthes).

Device: Adaptos®Ortho Wedge (bone grafting surgery)

No bone graft

SHAM COMPARATOR

OWHTO with unfilled bony defect of the osteotomy gap with a load bearing TomoFix® Medial High Tibia Plate (DePuy Synthes).

Procedure: OWHTO without bone grafting

chronOS® Wedge

ACTIVE COMPARATOR

Bone augmentation, after OWHTO, with chronOS® Wedge (DePuy Synthes, synthetic beta-TCP bone graft) in combination with a load bearing TomoFix® Medial High Tibia Plate (DePuy Synthes).

Device: chronOS® Wedge (bone grafting surgery)

Interventions

Adaptos®Ortho Wedge (bone grafting surgery) DEVICE

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.

Adaptos®Ortho Wedge

OWHTO without bone grafting PROCEDURE

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.

No bone graft

chronOS® Wedge (bone grafting surgery) DEVICE

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.

chronOS® Wedge

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biomendex Oy: lead

Study Sites (6)

Kanta-Häme Central Hospital

Hämeenlinna, Finland

Location

Meilahti Bridge Hospital, Helsinki University Hospital

Helsinki, Finland

Location

Pihlajalinna Kelloportti

Tampere, Finland

Location

Petz Aladár University Teaching Hospital

Győr, Hungary

Location

University of Szeged Szent-Györgyi Albert Clinical Center

Szeged, Hungary

Location

Szent György University Teaching Hospital

Székesfehérvár, Hungary

Location

MeSH Terms

Interventions

Bone Transplantation

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Mikko Manninen, MD, PhD

  Orton Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: October 7, 2022
• Study Start: April 8, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3); HU (3)