Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-21

Study Completion Date

2028-07-01

Brief Summary

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This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.

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Detailed Description

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This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).

All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.

Conditions

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Knee Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years
* Clinical diagnosis of knee OA

Exclusion Criteria

* If an active skin disease or infection is present at or near the injection site
* If the joint is infected or severely inflamed
* If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®
* If the patient has previously received treatment with a different non-absorbable injectable/implant
* If the patient has received a knee alloplasty or has any foreign material in the knee
* If the patient has undergone knee arthroscopy within the last 6 months
* If the patient has haemophilia or is in uncontrolled anticoagulant treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No