Clinical trial NCT03912116: Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
Official title: Adjunctive Use of Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis: Joint Replacement Surgery
Lead sponsor: BioTissue Holdings, Inc
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female, greater than 18 years of age
2. Primary diagnosis of unilateral osteoarthritis of the knee
3. Scheduled to undergo primary, unilateral TKA
4. ASA physical status 1, 2, or 3

Exclusion Criteria:

1. Patient has concurrent painful physical condition not strictly related to the knee surgery that may require analgesic treatment (such as NSAIDs or opioid) that may confound postsurgical assessments as determined by the investigator
2. Patient on chronic daily narcotic medication for knee pain based on medical history and Florida Prescription Drug Monitoring Program (E-FORCSE)
3. Allergy or contraindication to any of the study medications
4. Patient reported renal impairment based on medical history
5. Bodyweight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
6. History of previous fracture or open surgery on the knee being considered for TKA
7. History of patellar instability, e.g., Valgus deformity
8. History of inflammatory arthropathy (e.g., Rheumatoid arthritis, Lupus, etc.)
9. Use of cryoneurolysis, or cryoanalgesia, including iovera® device (Myoscience, Fremont, CA) on the operative knee within the last 6 months or planned during study duration
10. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might impact postsurgical pain or confound postsurgical assessments
11. Planned use of intra-articular steroid injections during the study.
12. Received any local anesthetic within 7 days of the planned TKA procedure aside from those part of the protocol
13. Planned use of potent inhalational agents or peripheral nerve block (e.g., femoral nerve block)
14. Current or planned use of neuraxial (epidural or intrathecal) opioids
15. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
16. History of suspected, or known, misuse, abuse, dependence of opioid analgesics, illicit drugs, prescription medicines, or alcohol within the past 2 years
17. Currently pregnant, nursing, or planning to become pregnant during the study

Primary outcomes:
measure: Difference in Pain at 2 weeks: visual analog scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Difference in Pain at 5-7 days: visual analog scale
timeFrame: 5-7 days
measure: Difference in Patient Satisfaction: Questionnaire
timeFrame: 2 weeks
measure: Difference in Quality of Life: SF-36
timeFrame: 2 weeks
measure: Difference in Subjective Outcome
timeFrame: 2 weeks
measure: Difference in pain medication consumption
timeFrame: 2 weeks
measure: Difference in range of motion between baseline and 2 weeks
timeFrame: 2 weeks
measure: Length of Hospital Stay
timeFrame: 5 days
measure: Difference in Number of Readmissions
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
Study officials:
References: