Outcome Comparison of Two Total Knee Arthroplasty Systems: e.Motion-Pro Versus Genesis II

NCT02276118 | Unknown

• 1 other identifier: E-1406/254-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, E.Motion-PS-Pro (B.Braun-Aesculap, Tuttlingen, Germany), a new mobile bearing knee system with a unique ball and socket post-cam mechanism was developed for use in total knee arthroplasty. This study aims to determine (1) whether the use of E.Motion-PS-Pro improves prosthesis fitness for the femur and tibia in terms of under- or over-hang incidence compared to an established successful prosthesis, Genesis II (Smith \& Nephew, Memphis, U.S.A.), (2) whether patients with this new prosthesis experience less pain and faster wound healing in early recovery phase, (3) whether patients with E.Motion-Pro reach functional plateaus faster than patients with Genesis II and the functional plateaus of patients with E.Motion-Pro are higher than those of patients with Genesis II.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

• prosthesis fit

  Component fitness will be evaluated by whether there is overhang (too wide or big) or underhang (too narrow or small) more than 2 mm at any of three sites: condyle, junction, and anterior flange

  from the start to end of surgery (expected average of 90 minutes)

• pain level during gait at 3 months after surgery

  Pain levels will be evaluated by asking how much pain patients feel during weight bearing gait at 3 months in 0-10 visual analog scale (0-no pain and 10-maximum pain)

  at 3 months after surgery

• knee swelling (circumference measured at the knee) at 3 months

  Knee swelling will be evaluated by measuring the leg circumference at the knee level (mid-patella), and the measured circumference will be compared with the preoperative circumference

  at 3 months after surgery

• flexion contracture and maximum flexion at 3 months

  Flexion contracture and further flexion will be measured by a single investigator using a 38-cm clinical goniometer with patients supine

  at 3 months after surgery

• the new American Knee Society (AKS) score at 6 months

  Patients will be evaluated at 6 months using the new scoring system of American Knee Society. The American Knee Society scoring system evaluates multiple aspects of outcomes: 1) Objective knee indicators (maximum points 80) - alignment (25), mediolateral (ML) stability (15), anteroposterior (AP) stability (10), range of motion (ROM) (30); 2) Knee score (maximum points 80) - symptoms (25), patient satisfaction (40), and expectation (15); 3) Function score (maximum points 100) - walking \& standing (30), standard activities (30), advanced activities (25), discretionary knee activities (15)

  at 6 months after surgery

Secondary Outcomes (10)

• whether balanced gaps were achieved

  from the start to end of surgery (expected average of 90 minutes)

• tourniquet time

  from the start to end of surgery (expected average of 90 minutes)

• blood volume drained via a vacuum drainage in the subcutaneous tissue

  from the end of surgery to removal of vacuum drainage (usually at 2 days after surgery)

• hemoglobin drop on postoperative 2 and 5 days

  at 2 and 5 days after surgery

• pain level during motion arc exercise at 2 and 6 weeks

  at 2 and 6 weeks after surgery

Study Arms (2)

e.motion PS Pro group

EXPERIMENTAL

the patients who receives total knee arthroplasty with the e.motion PS pro prosthesis

Device: device: e.motion PS Pro

Genesis II group

ACTIVE COMPARATOR

the patients who receives total knee arthroplasty with the Genesis II prosthesis

Device: device : Genesis II

Interventions

device: e.motion PS Pro DEVICE

patients will undergo total knee arthroplasty with e.motion PS Pro implant

e.motion PS Pro group

device : Genesis II DEVICE

patients will undergo total knee arthroplasty with Genesis II implant

Genesis II group

Eligibility Criteria

• Age: Up to 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are decided to undergo total knee arthroplasty with diagnosis of primary osteoarthritis

You may not qualify if:

• the diagnosis other than primary osteoarthritis
• previous history of infection or trauma requiring surgical treatment on the knee which will receive total knee arthroplasty
• patients of 80 years or older
• patients with systemic diseases that can affect functional outcomes of TKA

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Joint Reconstruction Center, Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tae Kyun Kim, MD, PhD

  Seoul National University Bundang Hospital

  STUDY CHAIR

Central Study Contacts

Tae Kyun Kim, MD, PhD

CONTACT

82-31-787-7196; osktk@snubh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2014
• First Posted: October 27, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 27, 2014

Record last verified: 2014-07

Locations

KR (1)