Trials / Unknown
UnknownNCT03302013
All Ligaments Left In Knee Arthroplasty Trial
Multi-center Clinical Study of Vanguard XP Bicruciate Knee System
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- Sponsor
- University of Oxford · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Compare the clinical and patient reported outcomes of the Vanguard XP Knee System to the Vanguard CR Knee System in patients with antero-medial osteoarthritis of the knee with an intact anterior cruciate ligament.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2016-09-05
- Primary completion
- 2021-09-04
- Completion
- 2022-01-01
- First posted
- 2017-10-04
- Last updated
- 2017-10-04
Locations
4 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03302013. Inclusion in this directory is not an endorsement.