Knee DeformityNCT05570760
Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy
A study testing Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting and chronOS® Wedge (bone grafting surgery) in people with Knee Deformity, run by Biomendex Oy at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Knee Deformity
- What is being tested?
- Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting and chronOS® Wedge (bone grafting surgery)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 8 Apr 2024to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Finland3 sites
Kanta-Häme Central Hospital
Hämeenlinna
Meilahti Bridge Hospital, Helsinki University Hospital
Helsinki
Pihlajalinna Kelloportti
Tampere
Hungary3 sites
Petz Aladár University Teaching Hospital
Győr
University of Szeged Szent-Györgyi Albert Clinical Center
Szeged
Szent György University Teaching Hospital
Székesfehérvár
About this study
Official title: Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy: A Randomized, Controlled, Partially Blinded, Multi-Center Trial.
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.
Read the detailed description
The study aims to evaluate the clinical performance and safety of Adaptos®Ortho Wedge (Biomendex Oy) bone graft material, when used for filling the medial osteotomy gap of the knee during OWHTO surgery.
This is partially randomized, subject and outcome assessor-blinded, controlled, multi-center study. The total study duration for each patient is planned to be 12 months. In total 6 visits per patient are scheduled in this study.
The study has three arms, and patients of all study arms are treated with medial OWHTO surgery to treat unicompartmental medial misalignment of the knee. Participants in the experimental arm (Arm 1) receive the investigational device, the osteotomy gap is filled with Adaptos®Ortho Wedge bone graft substitute. Participants in the control arm (Arm 2) receive the OWHTO treatment, where the osteotomy gap is left empty (no bone graft). Participants in the comparator device arm (Arm 3) receive the OWHTO treatment, where the osteotomy gap is filled with chronOS® Wedge bone graft substitute. In all three groups the metallic fixation plate (TomoFix®) is used for load bearing and for stabilizing the defect. The study device chronOS® Wedge (DePuy Synthes) and TomoFix® (DePuy Synthes) are CE-marked. The products are used within the indication.
The subject will be followed for twelve months following OWHTO.The radiological bone regeneration in the bony defect will be assessed at 6-weeks and 3-, 6-, and 12-months post-surgery.
- Conditions
- Knee Deformity
- Being tested
- Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting, chronOS® Wedge (bone grafting surgery)
- Keywords
- synthetic bone graft, Adaptos, high tibial osteotomy, orthopaedics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
OWHTO without bone graftingProcedure or surgery
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: chronOS® Wedge (bone grafting surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start8 Apr 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomendex Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikko Manninen, MD, PhD, Study director, Orton Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570760
- Sponsor's protocol ID
- AdaptosOrtho-001
- Status last verified
- Sep 2026
- First submitted
- 2 Aug 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy: A Randomized, Controlled, Partially Blinded, Multi-Center Trial.
- ClinicalTrials.gov ID
- NCT05570760
- Acronym / sponsor ID
- AdaptosOrtho-001
- Conditions
- Knee Deformity
- Keywords
- synthetic bone graft, Adaptos, high tibial osteotomy, orthopaedics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Biomendex OyIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study aims to evaluate the clinical performance and safety of Adaptos®Ortho Wedge (Biomendex Oy) bone graft material, when used for filling the medial osteotomy gap of the knee during OWHTO surgery.
This is partially randomized, subject and outcome assessor-blinded, controlled, multi-center study. The total study duration for each patient is planned to be 12 months. In total 6 visits per patient are scheduled in this study.
The study has three arms, and patients of all study arms are treated with medial OWHTO surgery to treat unicompartmental medial misalignment of the knee. Participants in the experimental arm (Arm 1) receive the investigational device, the osteotomy gap is filled with Adaptos®Ortho Wedge bone graft substitute. Participants in the control arm (Arm 2) receive the OWHTO treatment, where the osteotomy gap is left empty (no bone graft). Participants in the comparator device arm (Arm 3) receive the OWHTO treatment, where the osteotomy gap is filled with chronOS® Wedge bone graft substitute. In all three groups the metallic fixation plate (TomoFix®) is used for load bearing and for stabilizing the defect. The study device chronOS® Wedge (DePuy Synthes) and TomoFix® (DePuy Synthes) are CE-marked. The products are used within the indication.
The subject will be followed for twelve months following OWHTO.The radiological bone regeneration in the bony defect will be assessed at 6-weeks and 3-, 6-, and 12-months post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adaptos®Ortho Wedge | Experimental | Device: Adaptos®Ortho Wedge (bone grafting surgery)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). |
| No bone graft | Sham comparator | Procedure: OWHTO without bone graftingOWHTO with unfilled bony defect of the osteotomy gap with a load bearing TomoFix® Medial High Tibia Plate (DePuy Synthes). |
| chronOS® Wedge | Active comparator | Device: chronOS® Wedge (bone grafting surgery)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). |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Adaptos®Ortho Wedge |
| OWHTO without bone graftingAfter 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. | Procedure or surgery | No bone graft |
| chronOS® 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. | Device | chronOS® Wedge |
Primary outcome
Radiographic bone regeneration of the osteotomy defect, comparison between three treatment arms.
Time frame: Change from baseline to 12 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikko Manninen, MD, PhD study director
Orton Oy
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptos®Ortho Wedge (bone grafting surgery), OWHTO without bone grafting and chronOS® Wedge (bone grafting surgery) in people with Knee Deformity, run by Biomendex Oy at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone regeneration of the osteotomy defect, comparison between three treatment arms. (time frame: Change from baseline to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.