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

Last updated: October 24, 2024
Sponsor: Biomendex Oy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Holoprosencephaly

Birth Defects

Treatment

chronOS® Wedge (bone grafting surgery)

Adaptos®Ortho Wedge (bone grafting surgery)

OWHTO without bone grafting

Clinical Study ID

NCT05570760
AdaptosOrtho-001
  • Ages 25-60
  • All Genders

Study 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.

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

Total Participants: 87
Treatment Group(s): 3
Primary Treatment: chronOS® Wedge (bone grafting surgery)
Phase:
Study Start date:
April 08, 2024
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Meilahti Bridge Hospital, Helsinki University Hospital

    Helsinki,
    Finland

    Active - Recruiting

  • Töölö Hospital, Helsinki University Hospital

    Helsinki,
    Finland

    Site Not Available

  • Oulu University Hospital

    Oulu,
    Finland

    Site Not Available

  • Pihlajalinna Kelloportti

    Tampere,
    Finland

    Active - Recruiting

  • Pihlajalinna Koskisairaala

    Tampere,
    Finland

    Site Not Available

  • Turku University Hospital / Tyks Surgical Hospital

    Turku,
    Finland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.