Vitagel Revision Total Knee Arthroplasty

NCT01923805 | Terminated Results

• 1 other identifier: 12-1128
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit. Transfusion rates with the use of VG compared to the current standard of care will also be evaluated. The effectiveness of VG to potentially reduce pain, and increase return to function and quality of life will be assessed through the modified Knee Injury and Osteoarthritis Outcome Score (Modified KOOS), the Numerical Assessment Pain Scale (NAPS), and the SF-12 health survey. Analgesic use will be recorded post-operatively.

Conditions

Failed Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Transfusion Requirements

  The primary objective of this study is to test for significant differences in transfusion requirements in patients managed with RTKA.

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks.

Study Arms (2)

Treatment Group

EXPERIMENTAL

Vitagel

Device: Vitagel

Control

NO INTERVENTION

Standard of care for surgical hemostasis.

Interventions

Vitagel DEVICE

Vitagel

Treatment Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria in order to be considered appropriate candidates for participation in the study:
• Is scheduled for RTKA (may be the second stage/reimplantation of a two-stage revision for infection);
• Is able and willing to provide voluntary written informed consent for participation in the study and able to comply with protocol requirements;
• Is between the ages of 18 and 85 at the time of surgery. Both male and female will be included;
• Is physically and mentally willing and able to comply with the clinical and evaluation follow-up schedule;

You may not qualify if:

• Is known to be sensitive to any materials of bovine origin;
• Is undergoing a bilateral RTKA;
• Is undergoing a single component revision (i.e. tibial or femoral component only)
• Is undergoing a polyethylene revision only
• Is predonating autologous blood;
• Have a preoperative platelet count of less than 100,000
• Have a previous history of venous thromboembolism or deep vein thrombosis;
• Have a medical condition requiring anticoagulation
• Currently using Coumadin;
• Have a history of Heparin induced thrombocytopenia or Lovenox induced thrombocytopenia;
• Have a history of rheumatoid arthritis or inflammatory arthritis;
• Have peripheral vascular disease;
• Have evidence of bleeding or metabolic-based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder;
• Have a history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from the study if a baseline INR is greater than 1.3 or APTT greater than 32.4;
• Have a history of failed treatment for abuse of, or are actively abusing, illegal drugs, solvents, or alcohol;

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Stryker Nordic: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Results Point of Contact

• Title: Alison Klika; Research Program Manager, Adult Reconstruction
• Organization: Cleveland Clinic

klikaa@ccf.org

216-444-4954

Study Officials

• Trevor Murray, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 16, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)