Trial Outcomes & Findings for MONOVISC for Hip Joint Pain Relief Due to Osteoarthritis (NCT NCT04204083)

NCT ID: NCT04204083

Last Updated: 2025-01-28

Results Overview

Mean Change in Numerical Rating Scale (NRS) Pain on Walking in the Index Hip 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 outcome following treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

From Baseline to 6 Months

Results posted on

2025-01-28

Participant Flow

Only one hip \[Index Hip\] of each participant was included in this study

Participant milestones

Participant milestones
Measure	Monovisc Single injection of Monovisc into the index hip 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 Hip 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 hip joint
Age, Continuous	57.72 years STANDARD_DEVIATION 10.69 • n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	8 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	25 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Index Hip Right	13 Participants n=99 Participants
Index Hip Left	12 Participants n=99 Participants

PRIMARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the index hip joint
Numerical Rating Scale (NRS) Pain on Walking	-3.68 score on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

Mean change in Lequesne Hip Index Score from baseline to 6 months post injection. The Lequesne Hip Index is a three-section patient questionnaire that evaluates (1) pain or discomfort, (2) maximum distance walked, and (3) activities of daily living with 0 = best results / normal scores, to scores \>14 = extremely severe, to a maximum index score of 24 points. A negative value for the change in Lequesne Hip Index indicates improvement. A larger negative 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 hip joint
Lequesne Hip Index Score	-5.20 score on a scale Standard Deviation 3.46

SECONDARY outcome

Timeframe: From Baseline to 6 Months

Population: Intent To Treat (ITT)

The change from baseline to 6 months in hip 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) hip is bothering them today . The PGA Score is a validated 11-point Likert scale ranged 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 indicates less pain, and a better clinical outcome.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the index hip joint
Patient Global Assessment (PGA)	-3.52 score on a scale Standard Deviation 3.14

SECONDARY outcome

Timeframe: 6 Months

Population: Intent To Treat (ITT)

The post-treatment responder rate at 6 months 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 clinical outcome.

Outcome measures

Outcome measures
Measure	Monovisc n=25 Participants Single injection of Monovisc into the index hip joint
The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	20 Participants

SECONDARY outcome

Timeframe: 6 Months

The usage of Rescue Medication (RM) as based on the number of participants at 6 months post treatment that were NOT using acetominophen/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 hip joint
Number of Participants NOT Using Rescue Medication (Acetaminophen/Paracetamol)	21 Participants

Adverse Events

Monovisc

Serious events: 0 serious events

Other events: 9 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 hip joint
Infections and infestations Viral 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 Nasopharyngitis	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 Oral herpes	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 Sinusitis	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).
Endocrine disorders Diabetes insipidus	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).
Vascular disorders Hypertension	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).
Skin and subcutaneous tissue disorders Hyperhidrosis	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	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 Back 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).
Reproductive system and breast disorders Menorrhagia	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).

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