NCT03059706

Brief Summary

This study evaluates the efficacy of intra-articular administration of RegenoGel-OSP™ to treat pain and the safety and efficacy on subject's activity and quality of life following arthroscopic surgery due to degenerative or traumatic meniscal tear. adult subjects will be randomized and sequentially assigned to RegenoGel-OSP™ or placebo treatment on a 1:1 basis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 7, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

March 23, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

February 7, 2017

Last Update Submit

August 22, 2017

Conditions

Meniscal Tear

Outcome Measures

Primary Outcomes (3)

  • Efficacy of RegenoGel-OSP to treat pain following arthroscopic surgery

    The subjects will answer VAS (Visual Analog Score) questionnaire for grading of their pain level

    The questionnaires will filled for 6 months after surgery

  • Efficacy of RegenoGel-OSP on function following arthroscopic surgery

    The subjects will answer three questionnaires for grading of their symptoms and overall functional performance

    The questionnaires will filled for 6 months after surgery.

  • Efficacy of RegenoGel-OSP on function following arthroscopic surgery

    Radiograph of the terget knee will be obtained.

    Change from baseline at 6 months after surgery.

Secondary Outcomes (3)

  • Incidence of treatment-emergent adverse events.

    self-reported adverse events will be evaluated for 6 months follow-up.

  • The efficacy of RegenoGel-OSP on subject's activity and quality of life.

    The questionnaires will be filled for 6 months follow-up after surgery.

  • Incidence, relatedness and severity of treatment-emergent adverse events.

    Physical examination will be evaluated for 6 months follow-up

Study Arms (2)

RegenoGel-OSP™

EXPERIMENTAL
Device: RegenoGel-OSP™

Placebo

PLACEBO COMPARATOR
Other: saline

Interventions

RegenoGel-OSP™DEVICE

intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery

RegenoGel-OSP™
salineOTHER

intra-articular injection of saline after arthroscopic surgery

Placebo

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has signed and dated the informed consent form.
  • Subject is a male or female over the age of 45.
  • Patients scheduled for knee arthroscopic surgery due to degenerative or traumatic meniscal tear.

You may not qualify if:

  • Subject had any intra-articular injections to the intended study knee within 3 months prior to Screening.
  • Subject is unable to stop chronic administration of pain medications (including paracetamol), from the day before each study visit through completion of the study visit.
  • Subject has a history of Psoriatic Arthritis, Rheumatoid Arthritis,or any other inflammatory condition associated with arthritis.
  • Subject has a superficial wound in the area of the intended study knee.
  • Subject is scheduled for knee ligaments reconstructive surgery.
  • Subject has fever signs or symptoms of systemic infection or infection of the intended study knee.
  • Subject has known sensitivity to any of the treatment components, egg, rubber or latex.
  • Subject has a history of anaphylactic shock or other severe systemic response or other adverse event to human blood products.
  • Subject has a clinically significant abnormal finding (e.g., laboratory result or ECG).
  • Subject has known Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B or C viral infections, or acute or chronic liver disease.
  • Subject has ever had cellulitis of the lower extremities, a superficial or deep vein thrombosis, or a family history of a clotting disorders.
  • Subject receives any investigational device or product within 30 days of Visit l.
  • Subject is receiving an oral or injected anticoagulant.
  • Subject ever abused drugs or alcohol (self-reported).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Philip Rosinsky

CONTACT

0508990006prosinsky@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Orthopedic Surgery Department

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 23, 2017

Study Start

March 23, 2017

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

IL(1)