NCT01176292

Brief Summary

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable knee-osteoarthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

August 31, 2015

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

4.8 years

First QC Date

July 26, 2010

Results QC Date

July 23, 2013

Last Update Submit

November 4, 2020

Conditions

Knee Osteoarthritis

Keywords

total knee replacementhigh flexionrange of motionrotating platformTKA

Outcome Measures

Primary Outcomes (3)

  • Clinical Flexion

    Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.

    Preoperative, 4-6 weeks

  • Clinical Flexion

    Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.

    4-6 months

  • Clinical Flexion

    Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer.

    1 year

Secondary Outcomes (4)

  • Radiographic Flexion

    preoperative, 4-6 weeks

  • Radiographic Flexion

    1 year

  • Knee Society Score (KSS)

    1 year

  • Oxford Knee Score

    1 year

Study Arms (2)

Rotating Platform High-Flex Cruciate Substituting TKA

OTHER
Device: Rotating Platform High-Flex Cruciate Substituting TKA

Rotating Platform Cruciate Substituting TKA

OTHER
Device: Rotating Platform Cruciate Substituting TKA

Interventions

Rotating Platform High-Flex Cruciate Substituting TKADEVICE
Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKADEVICE
Rotating Platform Cruciate Substituting TKA

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 75 years old
  • Primary diagnosis of osteoarthritis of the knee
  • Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
  • Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

You may not qualify if:

  • Pregnant or lactating female subjects
  • Patients with post-traumatic or inflammatory arthritis
  • Patients with a fixed flexion contracture of greater than 20 degrees
  • Patients with advanced hip, spine, or ankle disease
  • Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Dr. William Hamilton
Organization
Anderson Orthopaedic Research Institute
research@aori.org
703-619-4411

Study Officials

  • William G Hamilton, MD

    Anderson Orthopaedic Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 26, 2010

First Posted

August 6, 2010

Study Start

August 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 23, 2020

Results First Posted

August 31, 2015

Record last verified: 2020-11