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Trial Outcomes & Findings for Post-op Treatment With Hyaluronic Acid Injections (NCT NCT01256788)

NCT ID: NCT01256788

Last Updated: 2019-01-08

Results Overview

The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

1 yr postop

Results posted on

2019-01-08

Participant Flow

Participant milestones

Participant milestones
Measure
Viscosupplementation
Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa
Saline Injection
Saline: 4 injections of 3 ml of sterile saline
No Treatment
No injection - pain/function questionnaires only through 1 year
Overall Study
STARTED
12
14
8
Overall Study
COMPLETED
7
6
5
Overall Study
NOT COMPLETED
5
8
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Viscosupplementation
Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa
Saline Injection
Saline: 4 injections of 3 ml of sterile saline
No Treatment
No injection - pain/function questionnaires only through 1 year
Overall Study
Lost to Follow-up
5
8
3

Baseline Characteristics

Post-op Treatment With Hyaluronic Acid Injections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Viscosupplementation
n=12 Participants
Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa
Saline Injection
n=14 Participants
Saline: 4 injections of 3 ml of sterile saline
No Treatment
n=8 Participants
No injections given
Total
n=34 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
n=5 Participants
13 Participants
n=7 Participants
7 Participants
n=5 Participants
30 Participants
n=4 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
Age, Continuous
57.8 years
STANDARD_DEVIATION 7.8 • n=5 Participants
55.5 years
STANDARD_DEVIATION 8.7 • n=7 Participants
56 years
STANDARD_DEVIATION 8.46 • n=5 Participants
56 years
STANDARD_DEVIATION 8.5 • n=4 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
5 Participants
n=5 Participants
19 Participants
n=4 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
8 Participants
n=7 Participants
3 Participants
n=5 Participants
15 Participants
n=4 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
14 participants
n=7 Participants
8 participants
n=5 Participants
34 participants
n=4 Participants

PRIMARY outcome

Timeframe: 1 yr postop

Population: Study ended earlier due to problematic recruitment issues related to a change in insurance payments. Each treatment groups experienced lost to follow up, therefore the number of participants analyzed is smaller than the number of participants enrolled for each group.

The Tegner Scoring system is a numeric scale range from 1 to 10, with each value indicating the ability to perform a specific activity. The scoring system is ordinal in nature and reflects lower to higher levels of activity participation, with higher numbers indicating a higher level of function.

Outcome measures

Outcome measures
Measure
Viscosupplementation
n=7 Participants
Hyaluronic acid injection Euflexxa: 4 injections of 2ml of Euflexxa
Saline Injection
n=4 Participants
Saline: 4 injections of 3 ml of sterile saline
No Treatment
n=3 Participants
Patients did not receive neither viscosupplementation nor saline.
Tegner Activity Level Scale Score
2.5781 score on a scale
Interval 1.0 to 5.0
3.5 score on a scale
Interval 1.0 to 5.0
3 score on a scale
Interval 1.0 to 5.0

Adverse Events

Viscosupplementation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Saline Injection

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Douglas Wyland

Steadman Hawkins Clinic of the Carolinas/Greenville Health System

Phone: 864-454-7422

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place