An interventional study of CLARIX FLO and Saline in Osteoarthritis: Joint Replacement Surgery, sponsored by BioTissue Holdings, Inc. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by BioTissue Holdings, Inc · Not applicable, Interventional, and Treatment
Total knee arthroplasty (TKA) is the most common joint replacement surgery and its incidence is expected to increase 673% to 3.48 million procedures annually by 2030. After more than 20 years of follow-up data, TKA is confirmed to be an effective treatment for knee osteoarthritis, however, postoperative pain management continues to be a challenge despite advances in surgical techniques and anesthetic practice to minimize discomfort and enhance recovery. This acute post-surgical pain caused by extensive tissue damage and inflammation in TKA leads to restricted post-operative knee range of motion (ROM) and ability to mobilize.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
Browse Osteoarthritis studies →BioTissue Holdings, Inc is the lead sponsor of 14 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100mg Amniotic Umbilical Cord Particulate in 8cc saline
Other: CLARIX FLO · Other: Saline
8cc saline
Other: Saline
100mg CLARIX FLO
Saline
Difference in Pain at 2 weeks: visual analog scale
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
Time frame: 2 weeks
Difference in Pain at 5-7 days: visual analog scale
Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)
Time frame: 5-7 days
Difference in Patient Satisfaction: Questionnaire
Questionnaire ranging from 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied, 4 (Dissatisfied), and 5 (Very dissatisfied).
Time frame: 2 weeks
Difference in Quality of Life: SF-36
Assessed by SF-36 (0-100 scale with 100 representing no disability)
Time frame: 2 weeks
Difference in Subjective Outcome
Oxford Knee Scale (score 0 most severe symptoms to 48 least symptoms)
Time frame: 2 weeks
Difference in pain medication consumption
opioid consumption (morphine equivalents)
Time frame: 2 weeks
Difference in range of motion between baseline and 2 weeks
degrees the knee joint can move
Time frame: 2 weeks
Length of Hospital Stay
Time frame: 5 days
Difference in Number of Readmissions
Time frame: 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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BioTissue Holdings, Inc