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Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Male or female ≥ 40 years of age at time of consent
Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period
Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period
Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period
Body mass index (BMI) ≤ 40 kg/m2
Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation

Exclusion Criteria:

Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis
Hemophilia
Achondroplasia
History of infection in the index joint
Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening
Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening
Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening
Prior arthroscopic or open surgery of the index knee within 12 months of screening
Planned / anticipated surgery of the index knee during the study period
Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Insulin dependent diabetes
History of or active Cushing's syndrome
Skin breakdown at index knee where procedure would take place
Women of child-bearing potential
Case history related to motor vehicle accident or workers compensation
Presence of hardware in the index knee (e.g. screws, plates)
Immunocompromised patients (TB, HIV, etc.)
Allergic reactions to acetaminophen and paracetamol

Sites / Locations

Hospital for Special Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dexamethasone delivery system

Arm Description

Outcomes

Primary Outcome Measures

Incidence of treatment emergent adverse events

Change from baseline in weekly mean of the pain intensity score

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night

Secondary Outcome Measures

Change from baseline in weekly mean of the pain intensity score

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night

Time of onset of pain relief

Change from baseline in KOOS-JR score (stiffness)

Using a response scale of none, mild, moderate, severe, and extreme

Change from baseline in KOOS-JR score (pain)

Using a response scale of none, mild, moderate, severe, and extreme

Change from baseline in KOOS-JR score (function)

Using a response scale of none, mild, moderate, severe, and extreme

Change in patient's global impression of scores assessed via office visits

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)

Change in clinical observer's global impression of scores assessed via office visits

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)

Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria

Average weekly consumption of rescue medications

Average total consumption of rescue medications

Full Information

NCT ID

NCT02873273

First Posted

August 5, 2016

Last Updated

September 28, 2018

Sponsor

Mark Figgie

Collaborators

Hospital for Special Surgery, New York

1. Study Identification

Unique Protocol Identification Number

NCT02873273

Brief Title

Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis

Official Title

A Pilot Study of a Dexamethasone Implant System in Humans

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

October 14, 2016 (Actual)

Primary Completion Date

September 21, 2017 (Actual)

Study Completion Date

September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mark Figgie

Collaborators

Hospital for Special Surgery, New York

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether a longer duration, controlled, sustained release dexamethasone delivery system would be more effective in helping patients with osteoarthritis reduce their pain, remain functional, and delay their need for knee replacement.

Detailed Description

The objectives of the study are to assess the dexamethasone delivery system for: Safety and tolerability Efficacy Formal statistical analysis to compare treatment groups will not be performed due to the small number of participants in this pilot study. Summary statistics will be assessed using the short form of the knee injury and osteoarthritis outcome score (KOOS JR) surveys and questionnaires to assess pain intensity, pain medication consumption and wound assessment.

6. Conditions and Keywords

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

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexamethasone delivery system

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day

Primary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Time Frame

Through 24 weeks

Title

Change from baseline in weekly mean of the pain intensity score

Description

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night

Time Frame

Weeks 12, 24

Secondary Outcome Measure Information:

Title

Change from baseline in weekly mean of the pain intensity score

Description

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable) at rest, during activity, and at night

Time Frame

Weekly through 24 weeks

Title

Time of onset of pain relief

Time Frame

Weekly through 24 weeks

Title

Change from baseline in KOOS-JR score (stiffness)

Description

Using a response scale of none, mild, moderate, severe, and extreme

Time Frame

Over 1, 2, 4, 8, 12, 24 weeks post treatment

Title

Change from baseline in KOOS-JR score (pain)

Description

Using a response scale of none, mild, moderate, severe, and extreme

Time Frame

Over 1, 2, 4, 8, 12, 24 weeks post treatment

Title

Change from baseline in KOOS-JR score (function)

Description

Using a response scale of none, mild, moderate, severe, and extreme

Time Frame

Over 1, 2, 4, 8, 12, 24 weeks post treatment

Title

Change in patient's global impression of scores assessed via office visits

Description

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)

Time Frame

Weeks 4, 12, 24

Title

Change in clinical observer's global impression of scores assessed via office visits

Description

Using a numeric rating scale for pain with a scale of 0 (no pain) to 10 (worst pain imaginable)

Time Frame

Weeks 4, 12, 24

Title

Percent of responders (defined as patients with high improvement in pain or function) according to OMERACT-OARSI criteria

Time Frame

Weeks 1, 2, 4, 8, 12, 24

Title

Average weekly consumption of rescue medications

Time Frame

Through 24 weeks

Title

Average total consumption of rescue medications

Time Frame

Through 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Male or female ≥ 40 years of age at time of consent Diagnosis of unilateral or bilateral knee osteoarthritis for at least 6 months prior to screening with confirmation of osteoarthritis according to the American College of Rheumatology Criteria for Classification of Idiopathic Osteoarthritis of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to screening or during the screening period Kellgren - Lawrence grade ≥2 on weight bearing anteroposterior femorotibial radiograph performed within 6 months prior to or during screening period Mean score of ≥ 5 and ≤ 10 on the 24 hour average pain score (0 - 10 Numeric Rating System) during the screening period Body mass index (BMI) ≤ 40 kg/m2 Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions Willingness to stop all pain medications except acetaminophen and paracetamol 14 days prior to implantation Exclusion Criteria: Fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee History of inflammatory arthritis including rheumatoid arthritis, juvenile inflammatory arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, reactive arthritis Hemophilia Achondroplasia History of infection in the index joint Intra-articular corticosteroid (investigational or marketed) in any joint within three months of screening Intra-articular hyaluronic acid (investigational or marketed) in the index knee within three months of screening Oral, inhaled, and intranasal corticosteroids (investigational or marketed) within one month of screening Prior arthroscopic or open surgery of the index knee within 12 months of screening Planned / anticipated surgery of the index knee during the study period Active or history of malignancy within the last five years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ Insulin dependent diabetes History of or active Cushing's syndrome Skin breakdown at index knee where procedure would take place Women of child-bearing potential Case history related to motor vehicle accident or workers compensation Presence of hardware in the index knee (e.g. screws, plates) Immunocompromised patients (TB, HIV, etc.) Allergic reactions to acetaminophen and paracetamol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Figgie, MD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Study of a Steroid Delivery System for Pain Relief Treatment in Patients With Knee Osteoarthritis

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