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NCT01810848 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity
A Phase 1 study, sponsored by OhioHealth.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01810848: Clinical Trial Phase 1 study, sponsored by OhioHealth.
NCT01810848 is a Phase 1 study that was terminated before completion, run by OhioHealth. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01810848, a Phase 1 study, was terminated before completion, sponsored by OhioHealth.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance of even low-levels of physical activity is critical for management of cardiac risk. Patients with osteoarthritis have been shown to have poorer aerobic conditioning, lower daily physical activity levels and lower self-efficacy for exercise than non-OA cohorts. It has been established that there exists a consistent gradient across activity groups indicating greater longevity and reduced risk of CHD, CVD, and stroke, in more active individuals. Available research suggests the greatest gains in cardiovascular fitness occur in moving a sedentary individual to even low levels of physical activity, and 12 weeks is enough to demonstrate change in the risk profile of at-risk individuals. Finally, appropriate levels of aerobic and strength training have been shown to be beneficial in treatment of osteoarthritis of the knee. This study will evaluate the effectiveness of hylan G-F 20 (single injection preparation) in promoting greater levels of physical activity and fitness as measured by MET level compared to an exercise-only cohort; evaluating both the change in physical function as well as the cardiovascular risk profile. This is a randomized, single-blinded clinical trial comparing injection of the knee joint with Hylan GF-20 to sham procedure. Subjects will undergo a regular exercise program for 6 months following randomization.
Interventions
- OTHER Control
- DEVICE Hylan G-F 20
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
Why NCT01810848 stopped before completion
NCT01810848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01810848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01810848 about?
NCT01810848 is a clinical study titled "Pilot Study of Therapy With Hylan G-F 20 Exercise Capacity". Osteoarthritis of the knee is a degenerative joint disease that involves degradation of the joint. Symptoms include joint tenderness, pain, stiffness, locking, and occasionally an effusion. Over 40 million Americans also have cardiovascular disease in addition to their OA. Initiation and maintenance...
What is the current status of trial NCT01810848?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2014-06. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01810848?
The interventions under investigation include: Control (OTHER), Hylan G-F 20 (DEVICE).
Who is sponsoring clinical trial NCT01810848?
This trial is sponsored by OhioHealth, which has 20 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01810848's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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