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

Primary Purpose

Knee Deformity

Status

Not yet recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Adaptos®Ortho Wedge (bone grafting surgery)

OWHTO without bone grafting

chronOS® Wedge (bone grafting surgery)

About this trial

This is an interventional treatment trial for Knee Deformity focused on measuring synthetic bone graft, Adaptos, high tibial osteotomy, orthopaedics

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects aged between 25 and less than 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
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.

Sites / Locations

Töölö Hospital, Helsinki University Hospital
Oulu University Hospital
Pihlajalinna Koskisairaala
Turku University Hospital / Tyks Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Active Comparator

Arm Label

Adaptos®Ortho Wedge

No bone graft

chronOS® Wedge

Arm Description

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).

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

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).

Outcomes

Primary Outcome Measures

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). Assessment longitudinally at 6-weeks and repeatedly at 3-, 6-, and 12-months post-surgery. The change between the treatment arms is compared considering all time points assessed.

Secondary Outcome Measures

Full Information

NCT ID

NCT05570760

First Posted

August 2, 2022

Last Updated

October 5, 2022

Sponsor

Biomendex Oy

1. Study Identification

Unique Protocol Identification Number

NCT05570760

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2022 (Anticipated)

Primary Completion Date

October 2026 (Anticipated)

Study Completion Date

October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biomendex Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Deformity

Keywords

synthetic bone graft, Adaptos, high tibial osteotomy, orthopaedics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adaptos®Ortho Wedge

Arm Type

Experimental

Arm Description

Arm Title

No bone graft

Arm Type

Sham Comparator

Arm Description

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

Arm Title

chronOS® Wedge

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Device

Intervention Name(s)

Adaptos®Ortho Wedge (bone grafting surgery)

Intervention Description

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 10 months.

Intervention Type

Procedure

Intervention Name(s)

OWHTO without bone grafting

Intervention Description

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 10 months.

Intervention Type

Device

Intervention Name(s)

chronOS® Wedge (bone grafting surgery)

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Change from baseline to 12 months.

Other Pre-specified Outcome Measures:

Title

Radiographic bone regeneration of the osteotomy defect, comparison between study arms with investigational and comparator device.

Description

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). Assessment longitudinally at 6-weeks and repeatedly at 3-, 6-, and 12-months post-surgery. The change between the two treatment arms is compared considering all time points assessed.

Time Frame

Change from baseline to 12 months.

Title

Bone union

Description

Bone union of the tibial posterior cortex is assessed on lateral radiographs. Assessed at 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

Questionnaire: KOOS (Knee Injury and Osteoarthritis Outcome Score)

Description

Patient-reported outcome measure (PROM) relating to knee pain and function. KOOS is a 42-item questionnaire. KOOS consists of 5 subscales; Pain, other Symptoms, Function/activities in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change of KOOS score from baseline to 12 months.

Title

Questionnaire: FJS (Forgotten Joint Score)

Description

Patient-reported outcome measure (PROM) focusing on patients' awareness of a specific joint in everyday life. FJS is a 12-item questionnaire. When calculating the total score for the FJS, all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100 to change the direction of the final score in such a way that high scores indicate a high degree of "forgetting" the joint-i.e. a low degree of awareness. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

Questionnaire: RAND-36

Description

Patient-reported outcome measure (PROM), HRQoL questionnaire. RAND-36 is a 36-item questionnaire. The original response category for subjects is from 1 (excellent) to 5 (poor). All items are then scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively, and so that a high score defines a more favourable health state. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

Questionnaire: 15D

Description

Patient-reported outcome measure (PROM), HRQoL questionnaire. The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults. It combines the advantages of a profile and a preference-based, single index measure. A set of utility or preference weights is used to generate the 15D score (single index number) on a 0-1 scale. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

NRS Knee / Leg Pain Intensity score

Description

Patient reported outcomes relating to pain intensity. Pain intensity is rated on a numeric rating scale where zero indicated no pain at all, and 10 represented the worst possible pain. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

NRS Knee / Leg Pain Interference score

Description

Patient reported outcomes relating to pain interference. Pain intensity is rated on a numeric rating scale where zero indicated no pain at all, and 10 represented the worst possible pain. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

NRS Knee / Leg Pain Frequency

Description

Patient reported outcomes relating to pain frequency. Pain frequency is rated on numeric rating scale where zero indicated no pain at all and 10 represented pain always. Assessed at preoperative visit, and 6 weeks, 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

Questionnaire: overall satisfaction to the procedure

Description

Procedure satisfaction questionnaire. The study subjects complete 5-point Likert scale satisfaction questionnaire. The response category for subjects is 1 (Very dissatisfied), 2 (Dissatisfied), 3 (Neither satisfied nor dissatisfied), 4 (Satisfied), and 5 (Very satisfied). Assessed at 6 weeks, and 3-, 6-, and 12- months post-operation.

Time Frame

Change from baseline to 12 months.

Title

Full loadbearing

Description

The date (or follow-up week, +/- 1 week) when a patient is capable for full loadbearing, to abandon crutches conclusively. Outcome measure will be assessed up to 3 months visit.

Time Frame

Up to 3 months post-operation.

Title

Knee CT scan

Description

Clinical assessment of bone regeneration, as based on computed tomography (CT) images of the knee.

Time Frame

6 months post-operation.

Title

Mechanical axis

Description

The change in the degree of an angle (degree) of the mechanical axis.

Time Frame

The change from baseline to 12- months post-operation.

Title

Usability questionnaire

Description

Questionnaire for surgeons' experiences on usability of the medical devices. 5-point Likert scale satisfaction questionnaire. The response category for subjects is 1 (Very dissatisfied), 2 (Dissatisfied), 3 (Neither satisfied nor dissatisfied), 4 (Satisfied), and 5 (Very satisfied).

Time Frame

Within 1 week after surgery.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged between 25 and less than 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mikko Manninen, MD, PhD

Phone

+358 50 4643355

mikko.manninen@orton.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Kaarlo Paakinaho, D.Sc.

kaarlo.paakinaho@biomendex.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mikko Manninen, MD, PhD

Organizational Affiliation

Orton Oy

Official's Role

Study Director

Facility Information:

Facility Name

Töölö Hospital, Helsinki University Hospital

City

Helsinki

Country

Finland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Henri Henttu, MD

Phone

+358 50 4274522

henri.henttu@hus.fi

First Name & Middle Initial & Last Name & Degree

Henri Henttu, MD

Facility Name

Oulu University Hospital

City

Oulu

Country

Finland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Juuso Heikkinen, MD, PhD

Phone

+358 40 7031233

juuso.heikkinen@ppshp.fi

First Name & Middle Initial & Last Name & Degree

Juuso Heikkinen, MD, PhD

Facility Name

Pihlajalinna Koskisairaala

City

Tampere

Country

Finland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Petri Sillanpää, MD, PhD

Phone

+358 40 513 1792

petri.sillanpaa@pihlajalinna.fi

First Name & Middle Initial & Last Name & Degree

Petri Sillanpää, MD, PhD

Facility Name

Turku University Hospital / Tyks Surgical Hospital

City

Turku

Country

Finland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inari Laaksonen, MD, PhD

Phone

+358 44 2772 776

inari.laaksonen@tyks.fi

First Name & Middle Initial & Last Name & Degree

Inari Laaksonen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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