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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012043-42-GB

Enrollment

170

Registered

2011-06-01

Start date

2011-07-11

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of human surgical sealant during total knee replacement and if this affects knee movement for the 1st year after surgery. MedDRA version: 13.1 Level: LLT Classification code 10057129 Term: Revision of total knee arthroplasty System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 13.1 Level: LLT Classification code 10044094 Term: Total knee replacement System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Evicel Product Name: Evicel, previously known as Quixil Pharmaceutical Form: Sealant INN or Proposed INN: Human fibrinogen/fibronectin Concentration unit: mg/ml milligram(s)/millilitre Con

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: What is the effect of a human surgical sealant (Evicel) on range of motion following total knee replacement measured at discharge, at 6 weeks, 3 months and 1 year.;Secondary Objective: The secondary outcome measures are: 1. Hopsital length of stay post-operatively 2. Knee circumference using a tape measure referenced from a set bony landmark 3. Post-operative knee function using the Oxford Knee Score and American Knee Society Score 4. Estimated total blood loss, measured using: estimated blood loss from operative swabs and suction; drop in haemoglobin and haematocrit in relation to body weight and height, according to the formula described by Gross (as clinical estimation alone is less accurate); and drainage from the knee drain at 24 hours. 5. Number of blood transfusions; the use of blood transfusion products will be based on individual clinical need according to the British Orthopaedic Association Blue Book Transfusion Guidelines;Primary end point(s): Range of Motion of the knee after TKR	—

Measure

Time frame

Main Objective: What is the effect of a human surgical sealant (Evicel) on range of motion following total knee replacement measured at discharge, at 6 weeks, 3 months and 1 year.;Secondary Objective: The secondary outcome measures are: 1. Hopsital length of stay post-operatively 2. Knee circumference using a tape measure referenced from a set bony landmark 3. Post-operative knee function using the Oxford Knee Score and American Knee Society Score 4. Estimated total blood loss, measured using: estimated blood loss from operative swabs and suction; drop in haemoglobin and haematocrit in relation to body weight and height, according to the formula described by Gross (as clinical estimation alone is less accurate); and drainage from the knee drain at 24 hours. 5. Number of blood transfusions; the use of blood transfusion products will be based on individual clinical need according to the British Orthopaedic Association Blue Book Transfusion Guidelines;Primary end point(s): Range of Motion of the knee after TKR

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026