Evaluating a new bone graft substitute for knee surgery
Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy: a Randomized, Controlled, Partially Blinded, Multi-Center Trial.
This study is testing a new bone graft substitute during knee surgery to see if it helps patients heal better compared to no graft or a different product.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | All |
| Sponsor | Biomendex Oy Industry-sponsored |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT05570760 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the performance and safety of the Adaptos®Ortho Wedge bone graft substitute during medial open wedge high tibial osteotomy (OWHTO) surgery. Participants will be randomly assigned to one of three groups: one receiving the Adaptos®Ortho Wedge, another with no bone graft, and a third using a comparator product, chronOS® Wedge. The study will monitor the patients over a 12-month period, with evaluations of bone regeneration at multiple intervals post-surgery. The goal is to determine if the new graft material can effectively support bone formation in the osteotomy gap.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 25 to 60 with varus malalignment of the knee, scheduled for OWHTO, and in good health.
Not a fit: Patients with previous knee area surgeries or those with a BMI over 30 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients undergoing knee surgery, potentially improving recovery and outcomes.
How similar studies have performed: While this approach is novel, similar studies using bone graft substitutes have shown promise in improving surgical outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 * 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 estrogens, estrogen-progestin therapy, or selective estrogens receptor modulators (SERMs) 3 months prior to and after the surgery. * 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.
Where this trial is running
Helsinki and 3 other locations
- Meilahti Bridge Hospital, Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Oulu University Hospital — Oulu, Finland (Not_yet_recruiting)
- Pihlajalinna Kelloportti — Tampere, Finland (Recruiting)
- Turku University Hospital / Tyks Surgical Hospital — Turku, Finland (Not_yet_recruiting)
Study contacts
- Study coordinator: Mikko Manninen, MD, PhD
- Email: mikko.manninen@orton.fi
- Phone: +358 50 4643355
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.