Effect of surgical sealant on range of motion in TKR

• Research type

  Research Study

• Full title

  The Effect of a Human Surgical Sealant on Range of Motion in Total Knee Replacement

• IRAS ID

  9556

• Contact name

  Neil Bradley

• Sponsor organisation

  Royal Surrey County Hospital NHS Trust

• Eudract number

  2009-012043-42

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Knee arthritis is a painful and debilitating condition. When the arthritis is severe and the knee becomes painful a total knee replacement (TKR) may be required. In the UK in 2006, more than 56,000 such operations were performed. During the procedure patients may lose up to 1200 mls of blood leading to transfusion or other significant complications such as haematoma formation which can result in post-operative pain and stiffness. Evicel is a human surgical sealant that when sprayed on to tissues during the operation can reduce bleeding. Previous studies on this medicine have shown that it can reduce blood loss and subsequent transfusion requirements following surgery. Other limited studies suggest that surgical sealants may reduce hospital length of stay, improve knee motion and are potentially cost effective.We hypothesise that the use of a surgical sealant will improve early knee function, reduce the recovery time and therefore shorten hospital stay. It may also prevent the development of debilitating stiffness, which can be severe in up to 7% of patients. A randomised single blind controlled trial will be performed. Patients undergoing a TKR will be randomly assigned to two groups: one group will receive Evicel during surgery and the second will receive none. The groups will be compared following surgery and assessed for knee movement, length of hospital stay and other factors including blood loss and knee function. Physiotherapists will measure patients?? knee movement at regular intervals for the first year post operatively. Patients will then exit the trial at one year. Neither the physiotherapists nor the patients will know which treatment group they have been allocated to. Following the study the results will be analysed and then presented at local, regional and national orthopaedic meetings for feedback before being submitted for peer review and publication.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/0627

• Date of REC Opinion

  11 Jul 2011

• REC opinion

  Further Information Favourable Opinion