The Effect of a Human Surgical Sealant on Range of Motion in Total Knee Replacement - Effect of surgical sealant on range of motion in TKR

Phase 1

• Conditions: se of human surgical sealant during total knee replacement and if this affects knee movement for the 1st year after surgery.; MedDRA version: 13.1Level: LLTClassification code 10057129Term: Revision of total knee arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 13.1Level: LLTClassification code 10044094Term: Total knee replacementSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2009-012043-42-GB
• Lead Sponsor: Royal Surrey County Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-01
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Inclusion criteria - Primary total knee replacement - Aged 18 years or over; no upper age limit - Male and female participants - Able to provide written informed consent and comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria - Abnormal clotting screen pre operatively - Taken warfarin within 7 days of the TKR - Known to need warfarin post-operatively - Known bleeding disorders - Complex primary total knee replacement or revision knee replacement - Inflammatory joint disease - Pre operative haemoglobin levels less than 11 g/dL before surgery - Dementia or other significant cognitive impairment - Known anaphylaxis or severe systemic reaction to human blood products - Pregnant or breast feeding - Participation in another clinical trial or planned during the study - Inability to comply or non-compliance with protocol - Inability to consent for themselves due to mental or physcial incapacity - Excessive bleeding during surgery that warrants the use of a surgical sealant (EvicelTM or another) would prevent the subject from being able to participate

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified