Trial Outcomes & Findings for MONOVISC for Ankle Joint Pain Relief Due to Osteoarthritis (NCT NCT04204278)

NCT ID: NCT04204278

Last Updated: 2025-01-28

Results Overview

Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Baseline to 6 Months

Results posted on

2025-01-28

Participant Flow

Only one ankle \[Index Ankle\] of each participant was included in this study.

Participant milestones

Participant milestones
Measure	Monovisc Single injection of MONOVISC into the index ankle joint
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MONOVISC for Ankle Joint Pain Relief Due to Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MONOVISC n=25 Participants Single injection of MONOVISC into the index ankle joint
Age, Continuous	52.16 years STANDARD_DEVIATION 14.26 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Index Ankle Right	13 Participants n=5 Participants
Index Ankle Left	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Ankle from baseline to 6 Months post injection. NRS is an 11-Point scale where 0=No Pain, 10=Worst Pain. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of MONOVISC into the index ankle joint
Numerical Rating Scale (NRS) Pain on Walking	-3.00 score on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean Change from baseline to 6 months in the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Rating System Score. AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. It incorporates both subjective and objective information in three parts to evaluate Pain, Function and Alignment. Patients report their pain (40 points), and function (50 points), and the evaluator assesses alignment (10 points). A total score is calculated by adding the three scores for final range from 0 (worst clinical status) to 100 points (best clinical status). A positive increase in value for the change in AOFAS score indicates improvement. A larger positive value indicates a higher level of improvement, and a better outcome.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of MONOVISC into the index ankle joint
American Orthopaedic Foot and Ankle Society (AOFAS) Score	16.08 score on a scale Standard Deviation 13.27

SECONDARY outcome

Timeframe: Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean change from baseline to 6 months in ankle pain post-treatment as measured by the Patient Global Assessment (PGA) Score. PGA Score records participant responses to their assessment of how much their STUDY (treated) ankle is bothering them today. The PGA Score is a validated 11-point Likert scale from 0=No Pain to 10=Worst Pain. A negative value for the change from baseline indicates improvement in PGA Score. A larger negative value (maximum -10.0) for the change from baseline indicates less pain and a better clinical outcome following treatment.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of MONOVISC into the index ankle joint
Patient Global Assessment (PGA) Score	-2.96 score on a scale Standard Deviation 1.97

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The post-treatment responder rate is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder to treatment. The criteria for response are (1) improvement in pain or physical function \>50% and an absolute change \>20 mm; or (2) improvement of \>20% with an absolute change \>10 mm in at least of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of MONOVISC into the index ankle joint
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	21 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetaminophen/paracetamol RM for pain or discomfort. A larger percentage of participants that were NOT using RM may correlate to a better clinical outcome in terms of pain.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of MONOVISC into the index ankle joint
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)	20 Participants

Adverse Events

Monovisc

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Monovisc n=25 participants at risk Single injection of MONOVISC into the index ankle joint
Gastrointestinal disorders Abdominal pain	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 Months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Infections and infestations Pharyngitis	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 Months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 1 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 Months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • Adverse Events were collected from the time of the Baseline Study Visit until Study Completion at 26 Weeks (6 Months). The definitions of adverse events and serious adverse events is the same as used in the clinicaltrials.gov definitions. The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE) were collected and coded using Medical Dictionary for Regulatory Activities (MedDRA).

Additional Information

Kara Mezger, Executive Director Clinical Affairs

Anika Therapeutics

Phone: 781.457.9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee INVESTIGATOR may publish the Data/Results with the consent of the SPONSOR if: 1. Publication is done after primary publication covering data from all participating sites, and provided the Data/Results do not contain any Confidential Information. 2. Eighteen (18) months has elapsed after entire completion of the Clinical Trial at all participating sites.
Publication restrictions are in place

Restriction type: OTHER