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Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. (ECHOGUIDE)

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Injection of corticosteroids (Diprostène®)
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
  • Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
  • Patient who has given free and informed consent.
  • Patient who has signed the consent form.
  • Patient affiliated or beneficiary of a health insurance plan.
  • Adult patient (≥18 years of age).

Exclusion Criteria:

  • No iconographic evidence of meniscal injury.
  • Associated lesions of the central pivot of the knee.
  • Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
  • Presence of a skin lesion at the infiltration sites.
  • Suspected soft tissue or joint infection.
  • Patient participating in research involving human subjects defined as Category 1.
  • Patient in an exclusion period as determined by another study.
  • Patient under court protection, guardianship or trusteeship.
  • Patient unable to give consent.
  • Patient for whom it is impossible to give informed information.
  • Pregnant, parturient or breastfeeding women.

Sites / Locations

  • Chu NimesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Meniscal wall infiltration group

Intra-articular infiltration group

Arm Description

Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.

The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly. Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe.

Outcomes

Primary Outcome Measures

Lysholm score before infiltration (intra-articular group)
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score before infiltration (meniscal wall group)
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (intra-articular group)
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (meniscal wall group)
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)

Secondary Outcome Measures

Arthroscopy required within six months of infiltration: (intra-articular group)
Yes/No and, if so, the date of the arthroscopy will be recorded.
Arthroscopy required within six months of infiltration: (meniscal wall group)
Yes/No and, if so, the date of the arthroscopy will be recorded.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (intra-articular group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Pain evaluated by the patient (meniscal wall group)
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Return to physical activity (intra-articular infiltration group)
The number of days taken for the patient to return to physical activity
Return to physical activity (meniscal wall infiltration group)
The number of days taken for the patient to return to physical activity
Adverse events in the intra-articular infiltration group
Collection of all possible adverse events from D0 to M3. Qualitative
Adverse events in the meniscal wall infiltration group
Collection of all possible adverse events from D0 to M3. Qualitative

Full Information

First Posted
January 21, 2022
Last Updated
September 20, 2022
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT05235854
Brief Title
Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.
Acronym
ECHOGUIDE
Official Title
Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group. The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Single-center, randomized, double-blind, controlled study comparing two management strategies.
Masking
ParticipantCare Provider
Masking Description
The patient will not know whether he has been randomized to the meniscal wall infiltration group or the intra-articular filtration group. The investigator following up the patients after infiltration will not know whether his:her patient has had an intra-articular infiltration or a meniscal wall infiltration.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meniscal wall infiltration group
Arm Type
Active Comparator
Arm Description
Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.
Arm Title
Intra-articular infiltration group
Arm Type
Active Comparator
Arm Description
The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly. Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe.
Intervention Type
Drug
Intervention Name(s)
Injection of corticosteroids (Diprostène®)
Intervention Description
Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.
Primary Outcome Measure Information:
Title
Lysholm score before infiltration (intra-articular group)
Description
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Time Frame
15 days before infiltration
Title
Lysholm score before infiltration (meniscal wall group)
Description
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Time Frame
15 days before infiltration
Title
Lysholm score after infiltration (intra-articular group)
Description
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Time Frame
3 months after infiltration
Title
Lysholm score after infiltration (meniscal wall group)
Description
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Time Frame
3 months after infiltration
Secondary Outcome Measure Information:
Title
Arthroscopy required within six months of infiltration: (intra-articular group)
Description
Yes/No and, if so, the date of the arthroscopy will be recorded.
Time Frame
6 months after infiltration
Title
Arthroscopy required within six months of infiltration: (meniscal wall group)
Description
Yes/No and, if so, the date of the arthroscopy will be recorded.
Time Frame
6 months after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
15 days before infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
1 week after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
2 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
3 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
4 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
5 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
6 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
7 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
8 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
9 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
10 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
11 weeks after infiltration
Title
Pain evaluated by the patient (intra-articular group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
12 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
15 days before infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
1 week after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
2 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
3 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
4 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
5 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
6 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
7 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
8 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
9 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
10 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
11 weeks after infiltration
Title
Pain evaluated by the patient (meniscal wall group)
Description
Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.
Time Frame
12 weeks after infiltration
Title
Return to physical activity (intra-articular infiltration group)
Description
The number of days taken for the patient to return to physical activity
Time Frame
Day 0 to Month 6
Title
Return to physical activity (meniscal wall infiltration group)
Description
The number of days taken for the patient to return to physical activity
Time Frame
Day 0 to Month 6
Title
Adverse events in the intra-articular infiltration group
Description
Collection of all possible adverse events from D0 to M3. Qualitative
Time Frame
Day 0 to 3 months after infiltration
Title
Adverse events in the meniscal wall infiltration group
Description
Collection of all possible adverse events from D0 to M3. Qualitative
Time Frame
Day 0 to 3 months after infiltration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2). Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography. Patient who has given free and informed consent. Patient who has signed the consent form. Patient affiliated or beneficiary of a health insurance plan. Adult patient (≥18 years of age). Exclusion Criteria: No iconographic evidence of meniscal injury. Associated lesions of the central pivot of the knee. Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4). Presence of a skin lesion at the infiltration sites. Suspected soft tissue or joint infection. Patient participating in research involving human subjects defined as Category 1. Patient in an exclusion period as determined by another study. Patient under court protection, guardianship or trusteeship. Patient unable to give consent. Patient for whom it is impossible to give informed information. Pregnant, parturient or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe MARCHAND, Dr.
Phone
+33 4.66.68.72.93
Email
philippe.marchand@chu-nimes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa MEGZARI
Phone
+33 4.66.68.42.36
Email
drc@chu-nimes.fr
Facility Information:
Facility Name
Chu Nimes
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MARCHAND
Email
philippe.marchand@chu-nimes.fr

12. IPD Sharing Statement

Learn more about this trial

Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.

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