GK9B: Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02175576
• Collaborator: (none)
• Enrollment: 306
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 144
• Patients Per Site: 153
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Rheumatoid Arthritis; Traumatic Arthritis; Lower Limb Deformity; Post-traumatic Deformity; Complications, Arthroplasty	Device: Vanguard XP Bicruciate Knee System; Device: Vanguard CR Knee System	N/A

Detailed Description

Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 306 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System
• Actual Study Start Date: Oct 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2026
• Anticipated Study Completion Date: Oct 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vanguard XP Bicruciate Knee System 153 patients receive Vanguard XP Bicruciate Knee System	Device: Vanguard XP Bicruciate Knee System; The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
Active Comparator: Vanguard CR Knee System 153 patients receive Vanguard CR Knee System	Device: Vanguard CR Knee System; The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.

Outcome Measures

Primary Outcome Measures

1. Change in Modified Knee Society Score [12 months]

   The objective component of the Knee Society score will be collected by clinical personnel. The pain and function component of the score will be patient complete questionnaire

Secondary Outcome Measures

1. Complications [10 year]

   Serious and device related adverse events will be collected for the duration of the study

2. Survivorship [10 year]

   KM survivorship will be calculated based on device revisions and removals through out duration of the study

3. Change in Patient Reported Outcome Measures on KOOS [12 months]

   Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including KOOS

4. Change in Patient Reported Outcome Measures on Oxford Knee Score [12 months]

   Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including Oxford Knee Score

5. Change in Patient Reported Outcome Measures on EQ 5D [12 months]

   Patients will complete questionnaires to determine overall satisfaction and outcomes of TKA including EQ-5D

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• cemented application of components

• bilateral subjects randomized by knee

• patients with pre-existing contralateral knee surgery

• painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved

• correction of varus, valgus, or posttraumatic deformity

• sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

Exclusion Criteria:

• cementless application of components

• BMI greater than or equal to 40

• use of Anterior Stabilized Bearings

• patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees

• correction or revision of previous joint replacement procedure on index knee

• infection

• sepsis

• osteomyelitis

Relative exclusion criteria:

• uncooperative patient or patient with neurological disorders who is incapable of following directions

• osteoporosis

• metabolic disorders which may impair bone formation

• osteomalacia

• distant foci of infections which may spread to the implant site

• rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram

• vascular insufficiency, muscular atrophy, neuromuscular disease

• incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Midwest Orthopaedics at Rush University Medical Center	Chicago	Illinois	United States	60605
2	University of Utah Orthopaedic Center	Salt Lake City	Utah	United States	84108

Sponsors and Collaborators

• Zimmer Biomet

Investigators

• Study Director: Kacy Arnold, RN, MBA, Zimmer Biomet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT02175576
• Other Study ID Numbers: ORTHO.CR.GK9B
• First Posted: Jun 26, 2014
• Last Update Posted: Sep 8, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Arthritis; Congenital Abnormalities

Study Results

No Results Posted as of Sep 8, 2021