Trial Outcomes & Findings for To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection (NCT NCT01895959)

Last Updated: 2020-11-18

Results Overview

The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

3 months

Results posted on

2020-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Subjects treated with Euflexxa
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=12 Participants Subjects treated with Euflexxa
Age, Continuous	59.17 years STANDARD_DEVIATION 9.32 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	4 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	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.

The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=12 participants at risk Subjects treated with Euflexxa
Musculoskeletal and connective tissue disorders knee pain	8.3% 1/12 • Number of events 1

Additional Information

Xiaojuan Li, PhD

University of California, San Francisco

Phone: 415-353-4909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place