Signature Personalised Patient Care System With the Vanguard Knee System Study
This study is currently recruiting participants.
Verified May 2013 by Biomet, Inc.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01092312
First received: March 7, 2010
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to determine whether the percentage cases which have ideal mechanical axial alignment using the Vanguard total Knee implant with the Signature cutting blocks is higher than those without the use of Signature when measured immediately post-operatively.
| Condition | Intervention |
|---|---|
|
Arthroplasty, Replacement, Knee |
Device: Vanguard Knee System with Signature Knee Guide Device: Vanguard Knee System with conventional Instruments |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study on the Signature Personalised Patient Care System With the Vanguard Knee System |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- Mechanical Axial Alignment [ Time Frame: Prior to Discharge: 0-2 weeks ] [ Designated as safety issue: No ]Femoral and tibial component alignment, femoral and tibial rotational alignment, tibial posterior slope
Secondary Outcome Measures:
- Clinical Outcome [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]American Knee Society Score, Oxford Knee Score
| Estimated Enrollment: | 628 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | May 2023 |
| Estimated Primary Completion Date: | May 2023 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Signature Knee Guide
Vanguard Knee System with Signature Knee Guide
|
Device: Vanguard Knee System with Signature Knee Guide
Use of Signature Knee Guide
|
|
Active Comparator: Conventional Approach
Vanguard Complete Knee System with Conventional Approach
|
Device: Vanguard Knee System with conventional Instruments
Use of Conventional instruments
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more of the knee compartments are involved
- correction of varus, valgus or posttraumatic deformity
- correction or revision of unsuccessful osteotomy (wedge cut from bone to improve alignment), or arthrodesis (fusion)
- need to obtain pain relief and improve function
- ability and willingness to follow instructions, including control of weight and activity level.
- a good nutritional state
- must have reached full skeletal maturity
- able and willing to undergo an MRI scan
Exclusion Criteria:
- infection
- sepsis
- osteomyelitis
- failure of a previous joint replacement
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092312
Locations
| United States, New York | |
| Insall Scott Kelly Institute | Enrolling by invitation |
| New York, New York, United States | |
| Australia, Queensland | |
| Logan Hospital | Recruiting |
| Brisbane, Queensland, Australia, 4131 | |
| Contact: Iulian Nusem 07 32998235 | |
| Principal Investigator: Iulian Nusem | |
| Australia, South Australia | |
| The Queen Elizabeth Hospital | Recruiting |
| Adelaide, South Australia, Australia, 5011 | |
| Contact: Graeme West 61 8 8222 8639 | |
| Austria | |
| The Orthopaedic Hospital Speising | Recruiting |
| Vienna, Austria | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| General Hospital Kreuzschwestern | Recruiting |
| Wels-Grieskirchen, Austria | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| Belgium | |
| St Luc General Hospital | Not yet recruiting |
| Brussels, Belgium | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| Denmark | |
| Aalborg University Hospital | Not yet recruiting |
| Aalborg, Denmark | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| France | |
| Medipole de Savoie | Recruiting |
| Chambery, France | |
| Contact: Maggie She maggie.shen@biomet.com | |
| Netherlands | |
| Amphia Ziekenhuis Breda | Not yet recruiting |
| Breda, Netherlands | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| Portugal | |
| Torres Verdras Hospital | Recruiting |
| Torres Verdras Hospital, Portugal | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| Sweden | |
| Danderyd Hospital | Not yet recruiting |
| Stockholm, Sweden | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
| United Kingdom | |
| Addenbrooke's Hospital | Not yet recruiting |
| Cambridge, United Kingdom | |
| Contact: Maggie Shen maggie.shen@biomet.com | |
Sponsors and Collaborators
Biomet, Inc.
Investigators
| Principal Investigator: | Gordon Morrison, MBChB | The Queen Elizabeth Hospital |
More Information
No publications provided
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01092312 History of Changes |
| Other Study ID Numbers: | BMET AU02 |
| Study First Received: | March 7, 2010 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Biomet, Inc.:
|
knee arthroplasty |
ClinicalTrials.gov processed this record on May 16, 2013