Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties

NCT ID: NCT02921594

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-08-16

Brief Summary

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Primary: The primary objective of this pilot study is to compare the intraarticular kinematics by fluoroscopy of Vanguard XP to that of Vanguard CR.

Secondary: The secondary objective of this pilot study is to compare the standing balance by force plate of patients with the Vanguard XP prosthesis to those who have Vanguard CR prosthesis. Furthermore, we wish to assess isometric quadriceps muscle strength in both groups.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Total knee arthroplasty with Vanguard XP

The new Vanguard XP Total knee arthroplasty system is a further development of the Vanguard TKA. The new Vanguard XP system both cruciate ligaments are preserved.

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty with Vanguard XP

Intervention Type DEVICE

Total knee arthroplasty with Vanguard CR

Intervention Type DEVICE

Total knee arthroplasty with Vanguard CR

Total knee arthroplasty system without preservation of the anterior cruciate ligament

Group Type ACTIVE_COMPARATOR

Total knee arthroplasty with Vanguard XP

Intervention Type DEVICE

Total knee arthroplasty with Vanguard CR

Intervention Type DEVICE

Interventions

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Total knee arthroplasty with Vanguard XP

Intervention Type DEVICE

Total knee arthroplasty with Vanguard CR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Participant in the XP vs. CR study (inherited traits from study inclusion)
* Overall healthy. Have attended standard physiotherapy after unilateral total knee replacement
* Are able to perform the tasks
* Excellent clinical scores (Oxford Knee Score above 39 at 1 year follow up)

Exclusion Criteria

* Knee pain above 20 on a 0-100 visual analogue scale
* Any clinical relevant pain from adjacent joints
* Active Knee flexion below 100
* Signs of implant migration, loosening, and implant mal-alignment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders Troelsen

Professor, MD, PhD, dr.med

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Orthopaedic Surgery, Copenhagen University Hospital Hvidovre

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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XPvsCR_Fluoroscopi_v.1.0

Identifier Type: -

Identifier Source: org_study_id

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