A prospective randomised controlled trial investigating three dimensional knee joint kinematics in total knee replacement – a comparison of cruciate retaining, posterior cruciate sacrificing and medially stabilised designs.

A prospective randomised controlled trial investigating three dimensional knee joint kinematics in patients with osteoarthritis undergoing total knee replacement – a comparison of cruciate retaining, posterior cruciate sacrificing and medially stabilised designs.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001278729

Acronym

Medacta knee kinematics

Enrollment

Registered

2013-11-19

Start date

2014-07-01

Completion date

2016-10-06

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an investigator initiated study, aiming to assess the prosthetic performance of total knee replacements (TKR) and to determine whether abnormal movement of the replaced knee has an impact upon function and pain at one year post-operatively. By using a prospective analysis of patients randomized to receive TKR of different designs, this study aims to determine the effect the type of prosthesis has on gait, three-dimensional joint movement plus both clinical and patient reported outcomes. In order to achieve this, joint motion, ground reaction forces and muscle activity will be recorded simultaneously from each subject during four test conditions; level walking, stair ascent, stair descent and chair rise. Limb alignment, pain and functional assessments will also be evaluated, to assist in determining variables associated with improved functional outcomes following TKR.

Interventions

All participants in this trial will receive a total knee replacement. The prosthesis used will be the GMK Total Prosthesis from Medacta International SA. Randomisation will allocate patients to have one of three different types of prosthesis from this suite of prostheses. These are (1) posterior cruciate ligament retaining prosthesis, (2) a posterior cruciate ligament sacrificing/subsituting prosthesis and (3) a medially stabilised prosthesis - the GMK Sphere. The key differences between these prostheses is the level of antero-posterior constraint and the way in which the posterior cruciate ligament is handled. The approximate duration for knee replacement surgery is 90 minutes, the standard operative time for all elective knee replacement surgery, regardless of the device being utilised.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

i) on the waiting list for primary total knee replacement due to osteoarthritis at St Vincent's Hospital, Melbourne ii) knee replacement performed by one of three joint replacement surgeons at St Vincent's Hospital whose prosthesis of choice is the Medacta GMK Knee System

Exclusion criteria

i) Surgery for neoplastic disease ii) Inability to provide informed consent

Outcome results