NCT06027697

Brief Summary

The goal of this observational study is to evaluate the technique of subchondroplasty in patients with advanced knee osteoarthritis. The main question it aims to answer is: • Does the subchondroplasty technique with the administration of AccuFill Porous Bone Substitute Material (BSM) is effective in the relief of mechanical pain in patient with knee osteoarthritis ? Participants will go under a minimally invasive surgery procedure (subchondroplasty) and fulfil 3 validated questionnaires to assess pain, functional impairments and subjective improvement. This study will be conducted for 4 years.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
28mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Dec 2023Sep 2028

First Submitted

Initial submission to the registry

August 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Expected
Last Updated

September 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

August 31, 2023

Last Update Submit

August 31, 2023

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisSubchondroplastyKnee mechanical painAccuFill Porous Bone Substitute MaterialMinimally invasive surgical procedure

Outcome Measures

Primary Outcomes (1)

  • Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to 3 months.

    Visual Analog Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression. It will helped the patient to assess the perceived mechanical knee pain on a horizontal, non-calibrated line of 10 cm, ranging from very low (0) to very high (10)

    Month 3

Secondary Outcomes (6)

  • Change from baseline (inclusion) in Patient-Reported Pain Scores on the Visual Analog Scale (VAS) to each visits

    Week 3, Week 6, Month 6, Month 12, Month 24, Month 36, Month 48

  • Change from baseline (inclusion) in International Knee Documentation Committee (IKDC) score to each visits

    Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48

  • Change from baseline (inclusion) for the Knee injury and Osteoarthritis Outcome Score (KOOS) to each visits

    Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48

  • Rate of adverse events

    Week 3, Week 6, Month 3, Month 6, Month 12, Month 24, Month 36, Month 48

  • Radiography and MRI evolution of the knee lesions from baseline (inclusion) to 24 months

    Month 24

  • +1 more secondary outcomes

Study Arms (1)

Subchondroplasty

AccuFill Porous Bone Substitute Material (BSM) will be administrated to the patient during a subchondroplasty procedure (treatment visit). During the inclusion visit and the follow-up visits (Week 3, Week 6; Month 3, Month 6, Month 12, Month 24, Month 36, Month 48) the doctor will proceed the usual clinical exam and the patients will fulfil the validated questionnaires and scales to assess pain, functional impairments and subjective improvement.

Device: AccuFill® Porous Bone Substitute Material (BSM)

Interventions

AccuFill® Porous Bone Substitute Material (BSM)DEVICE

The patient will undergo a minimally invasive surgery procedure (subchondroplasty) to receive the medical device AccuFill® Porous Bone Substitute Material (BSM).

Also known as: Subchondroplasty
Subchondroplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who go for a consultation for refractory mechanical knees pain

You may qualify if:

  • Patient 18 years of age or older;
  • Patient with a Body Mass Index ≤35 (BMI=kg/m2);
  • Patient with Kellgren-Lawrence grade 3-4 Osteoarthritis, as reviewed on MRI and plain radiography;
  • Patient with knee bone marrow lesions confirmed by MRI result at least 3 months before the intervention;
  • Patients with degenerative knee pathology at the prosthetic stage (outdated medical treatments), with a frontal deformity of less than 12°, (and wishing to avoid or delay the prosthetic procedure as much as possible) / goniometry);
  • Patient with unbearable mechanical pain with a walking perimeter limited at 500 m
  • Patient with non-surgical treatment failure (infiltration of Platelet Rich Plasma (PRP), corticoids, acid hyaluronic);
  • Patient who agrees to participate in the study and who signed the informed non-opposition form;
  • Patient physically and mentally willing and able, in the Investigator's opinion at the time of enrolment, to be compliant with the protocol including all follow-up visits, survey completion, weight- bearing restrictions, and post-operative rehabilitation;
  • Patient with social protection.

You may not qualify if:

  • Patient with a Body Mass Index \> 35 (BMI=kg/m2);
  • Patient with inflammatory rheumatic pathologies;
  • Patient with frontal deformities (varus, valgus) of more than 12°;
  • Patient with degenerative pathologies at the operative stage but likely to benefit from a conservative intervention (osteotomy), except if the knee is centred;
  • Patient with stiff knees (more than 20° of flexum and/or less than 90° of flexion);
  • Patient with painful severe femoro-patellar osteoarthritis;
  • Patient with contraindications for Magnetic Resonance Imaging (MRI);
  • Patient with history of systemic diseases which could contribute to secondary arthropathies (e.g., sickle cell disease, hemochromatosis, or autoimmune disease);
  • Patient with history of cognitive-behavioural disorders that could interact with assessment by self-questionnaire;
  • Patient with local or general infection or suspicion of infection;
  • Patient with severe coagulation disorders;
  • Patient with primary bone tumour in the knee area,
  • Patient with undercurrent serious pathology with life expectance \< 2 years;
  • Patient who has forfeited their freedom by administrative or legal award, or is under guardianship or under limited judicial protection;
  • Patients who cannot read or write French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Paris Bercy

Charenton-le-Pont, 94220, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Guy Mylle, Dr

CONTACT

01 44 01 01 02guymylle@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion (Estimated)

September 1, 2028

Last Updated

September 7, 2023

Record last verified: 2023-08

Locations

FR(1)