Chondropathy/Degenerative Joint Disease (DJD), Meniscus Tear
Conditions
Keywords
viscosupplementation, meniscus tear, degenerative joint disease
Brief summary
This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a booster injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up. The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.
Interventions
DEVICEEuflexxa
4 injections of 2ml of Euflexxa
OTHERSaline
4 injections of 3 ml of sterile saline
Sponsors
Ferring Pharmaceuticals
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
The two treatment groups were: 1. Received saline injection 2. Received viscosupplementation injection
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD * Over 40 years of age * A daily knee pain above 20mm on a 100mm visual analogue scale
Exclusion criteria
* Previous recipient of viscosupplementation injections * Had rheumatoid arthritis or other inflammatory arthritis * Had intra-articular steroid injections within the previous 2 months * Invasive knee procedures within the past 6 months * Contraindications to hyaluronate (an allergy) * Medications that could interfere with the planned interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tegner Activity Level Scale Score | 1 yr postop | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Viscosupplementation Hyaluronic acid injection
Euflexxa: 4 injections of 2ml of Euflexxa | 12 |
| Saline Injection Saline: 4 injections of 3 ml of sterile saline | 14 |
| No Treatment No injections given | 8 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 8 | 3 |
Baseline characteristics
| Characteristic | Saline Injection | No Treatment | Viscosupplementation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 7 Participants | 10 Participants | 30 Participants |
| Age, Continuous | 55.5 years STANDARD_DEVIATION 8.7 | 56 years STANDARD_DEVIATION 8.46 | 57.8 years STANDARD_DEVIATION 7.8 | 56 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 14 participants | 8 participants | 12 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 4 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 14 | 0 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 | 0 / 8 |
Outcome results
Primary
Tegner Activity Level Scale Score
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Viscosupplementation | Tegner Activity Level Scale Score | 2.5781 score on a scale |
| Saline Injection | Tegner Activity Level Scale Score | 3.5 score on a scale |
| No Treatment | Tegner Activity Level Scale Score | 3 score on a scale |