Trial Outcomes & Findings for The MONOVISC Hip Osteoarthritis Study (NCT NCT02698865)

Last Updated: 2021-12-01

Results Overview

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. Walking Pain Score is measured by question A1 on the WOMAC 3.1 Index. The WOMAC questionnaire used in this study was administered in the Numerical rating scale (NRS) format. Question A1 on the WOMAC 3.1 Index measures the amount of pain that a participant has when walking on a flat surface. It is one question that is collected on a scale from 0 to 10 where a score of 0 indicates no pain and a score of 10 indicates extreme pain.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

220 participants

Primary outcome timeframe

Baseline and Day 180

Results posted on

2021-12-01

Participant Flow

Participant milestones

Participant milestones
Measure	Monovisc Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Overall Study STARTED	140	80
Overall Study Treated	140	80
Overall Study COMPLETED	105	47
Overall Study NOT COMPLETED	35	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Monovisc Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Overall Study Other	11	11
Overall Study Withdrawal by Subject	20	16
Overall Study Physician Decision	0	4
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

The MONOVISC Hip Osteoarthritis Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monovisc n=140 Participants Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline n=80 Participants Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.	Total n=220 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 9.55 • n=5 Participants	59.4 Years STANDARD_DEVIATION 10.80 • n=7 Participants	58.8 Years STANDARD_DEVIATION 10.01 • n=5 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	46 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	34 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=5 Participants	70 Participants n=7 Participants	190 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants	75 Participants n=7 Participants	208 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Day 180

Population: Safety Analysis Set (SAS) consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure (OM).

Outcome measures

Outcome measures
Measure	Monovisc n=105 Participants Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline n=47 Participants Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 180	-1.75 Units on a scale Standard Deviation 2.88	-1.53 Units on a scale Standard Deviation 3.21

SECONDARY outcome

Timeframe: Baseline, Day 14, 28, 60 and 120

Population: SAS consists of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received. Here 'n'(number analyzed) signifies participants who were evaluable at specified timepoints.

Outcome measures

Outcome measures
Measure	Monovisc n=140 Participants Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline n=80 Participants Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 Change at Day 14	-1.44 Units on a scale Standard Deviation 2.32	-1.16 Units on a scale Standard Deviation 2.14
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 Change at Day 28	-1.42 Units on a scale Standard Deviation 2.46	-1.13 Units on a scale Standard Deviation 2.19
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 Change at Day 60	-1.89 Units on a scale Standard Deviation 2.76	-1.75 Units on a scale Standard Deviation 2.31
Change From Baseline in Walking Pain as Measured by Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Score at Day 14, 28, 60 and 120 Change at Day 120	-1.97 Units on a scale Standard Deviation 2.79	-1.58 Units on a scale Standard Deviation 2.8

Adverse Events

Monovisc

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Monovisc n=140 participants at risk Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline n=80 participants at risk Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Cardiac disorders Mitral Valve Prolapse	0.71% 1/140 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.	0.00% 0/80 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.
Surgical and medical procedures Hip Arthroplasty	0.71% 1/140 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.	0.00% 0/80 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.

Other adverse events

Other adverse events
Measure	Monovisc n=140 participants at risk Participants received the intra-articular injections of 4 mL (milliliter) monovisc high molecular weight hyaluronan as active treatment into the hip joint on Day 1 and then second injection on Day 31.	Saline n=80 participants at risk Participants received the intra-articular injections of 4 mL (milliliter) physiologic saline as control treatment into the hip joint on Day 1 and then second injection on Day 31.
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 25/140 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.	15.0% 12/80 • Up to 36 months Safety Analysis Set (SAS) consisted of all randomized participants who were enrolled in the study and received either Monovisc or Saline and were analyzed as per treatment received.

Additional Information

FRANCHISE MEDICAL DIRECTOR

DePuy Synthes

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER