All Ligaments Left In Knee Arthroplasty Trial (ALLIKAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03302013|
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : October 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Osteoarthritis of Knee Nos||Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System Procedure: Vanguard CR Single Cruciate Retaining Knee System||Not Applicable|
The purpose of the proposed ALLIKAT study (All Ligaments Left in Knee Arthroplasty Trial) is to evaluate the early outcome of a Total Knee Replacement device that retains both cruciate (Vanguard XP) by comparing it with a control group of patients implanted with an established single cruciate retaining device (Vanguard CR). The study also aims to examine short and long term descriptive cohort outcome data. A small preference cohort group of 60 patients receiving the Vanguard XP Knee System will be recruited alongside the RCT group. This data will be used to confirm the external validity of the RCT group and to contribute to the safety data for the British Orthopaedic Association's Beyond Compliance Programme.
Evaluation will include intra-operative and post-operative complications, longer term survivorship and patient reported outcome measures.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Multi-center Clinical Study of Vanguard XP Bicruciate Knee System|
|Actual Study Start Date :||September 5, 2016|
|Estimated Primary Completion Date :||September 4, 2021|
|Estimated Study Completion Date :||January 2022|
Experimental: Vanguard XP Knee Replacement Surgery
Participants randomised in this group will receive the Vanguard XP Bi-cruciate Retaining Knee Replacement System. This total knee replacement device (Vanguard XP) and surgical procedure retain the anterior cruciate ligament in the knee.
Procedure: Vanguard XP Bi-cruciate Retaining Knee Replacement System
Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
Active Comparator: Vanguard CR Knee Replacement Surgery
Participants randomised to this group will receive the Vanguard CR Single Cruciate Retaining Knee Replacement Surgery. This total knee replacement device (Vanguard CR) and surgical procedure sacrifice the anterior cruciate ligament and replaces it with artificial support. This is currently the standard practice for knee replacement surgery in the NHS.
Procedure: Vanguard CR Single Cruciate Retaining Knee System
Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
- Oxford Knee Score-Activity & Participation Questionnaire (OKS-APQ) [ Time Frame: 3 years post randomisation ]Patient Reported Outcome Score - disease specific
- EQ-5D-3L [ Time Frame: Post-operation (within 6 weeks); 1 & 3 years post randomisation ]Quality of Life Patient Reported Outcome Score
- Forgotten Joint Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]Patient Reported Outcome Score - disease specific
- American Knee Society Score [ Time Frame: Post operation (within 6 weeks), 1, 2 & 3 years post randomisation ]Functional Assessment of the knee
- Complications [ Time Frame: Post operation (within 6 weeks), 1 & 3 years post randomisation ]Adverse events and complications related to the knee surgery
- Radiographic Assessment [ Time Frame: 1 & 3 Years Post Randomisation ]Evaluation of x-rays to assess Alignment, Radiolucency, Loosening, Fixation/Migration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302013
|Contact: Rachel Dorman||00441865227715||ALLIKAT@ndorms.ox.ac.uk|
|Contact: Cushla Cooper||00441865737643||ALLIKAT@ndorms.ox.ac.uk|
|Oxford University Hospitals NHS Foundation Trust||Recruiting|
|Headington, Oxford, United Kingdom, OX3 7HE|
|Contact: Pam Lovegrove, RN|
|Principal Investigator: William Jackson|
|Sub-Investigator: Andrew J Price|
|Sub-Investigator: Nicholas J Bottomley|
|The Royal Orthopaedic Hospital NHS Foundation Trust||Recruiting|
|Birmingham, United Kingdom, B31 2AP|
|Contact: Dionne Wortley, RN|
|Principal Investigator: Faisal Hussain|
|North Bristol NHS Trust||Recruiting|
|Bristol, United Kingdom, BS9 3QN|
|Contact: Rachel Bray, RN|
|Principal Investigator: Andrew J Porteous|
|Sub-Investigator: James Murray|
|Frimley Health NHS Foundation Trust||Recruiting|
|Frimley, United Kingdom, GU16 7UJ|
|Contact: Justine Amero, RN|
|Principal Investigator: Hugh Chissell|
|Sub-Investigator: Graham Smith|
|Principal Investigator:||Andrew Price||University of Oxford|