Amniotic Umbilical Cord Particulate During Total Knee Arthroplasty

NCT03912116 | Withdrawn

• 1 other identifier: CLARIX- CS007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis: Joint Replacement Surgery

Outcome Measures

Primary Outcomes (1)

• Difference in Pain at 2 weeks: visual analog scale

  Pain assessed using 100mm visual analog scale (0 to 100 worst possible pain)

  2 weeks

Secondary Outcomes (8)

• Difference in Pain at 5-7 days: visual analog scale

  5-7 days

• Difference in Patient Satisfaction: Questionnaire

  2 weeks

• Difference in Quality of Life: SF-36

  2 weeks

• Difference in Subjective Outcome

  2 weeks

• Difference in pain medication consumption

  2 weeks

Study Arms (2)

Amniotic Umbilical Cord Particulate Injection

EXPERIMENTAL

100mg Amniotic Umbilical Cord Particulate in 8cc saline

Other: CLARIX FLO; Other: Saline

Saline Injection

PLACEBO COMPARATOR

8cc saline

Other: Saline

Interventions

CLARIX FLO OTHER

100mg CLARIX FLO

Amniotic Umbilical Cord Particulate Injection

Saline OTHER

Saline

Amniotic Umbilical Cord Particulate Injection; Saline Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Patient on chronic daily narcotic medication for knee pain based on medical history and Florida Prescription Drug Monitoring Program (E-FORCSE)
• Allergy or contraindication to any of the study medications
• Patient reported renal impairment based on medical history
• Bodyweight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
• History of previous fracture or open surgery on the knee being considered for TKA
• History of patellar instability, e.g., Valgus deformity
• History of inflammatory arthropathy (e.g., Rheumatoid arthritis, Lupus, etc.)
• 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
• Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might impact postsurgical pain or confound postsurgical assessments
• Planned use of intra-articular steroid injections during the study.
• Received any local anesthetic within 7 days of the planned TKA procedure aside from those part of the protocol
• Planned use of potent inhalational agents or peripheral nerve block (e.g., femoral nerve block)
• Current or planned use of neuraxial (epidural or intrathecal) opioids
• 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

Sponsors & Collaborators

• BioTissue Holdings, Inc: lead

Study Sites (1)

Orange Park Medical Center

Orange Park, Florida, 32073, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: April 9, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Locations

US (1)