E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Use of human surgical sealant during total knee replacement and if this affects knee movement for the 1st year after surgery. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057129 |
E.1.2 | Term | Revision of total knee arthroplasty |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10044094 |
E.1.2 | Term | Total knee replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Range of Motion of the knee after TKR |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The study will be completed when the last patient has been assessed at 1 year post total knee replacement. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |