Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA) - Full Text View

Purpose

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.

Condition	Intervention
Knee Osteoarthritis	Device: Rotating Platform High-Flex Cruciate Substituting TKA Device: Rotating Platform Cruciate Substituting TKA

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:

Clinical flexion [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.
Clinical flexion [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.
Clinical flexion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.
Clinical flexion [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Maximum, passive flexion and extension in the supine position will be measured and recorded using a long goniometer.

Secondary Outcome Measures:

Radiographic flexion [ Time Frame: 4-6 weeks ] [ Designated as safety issue: No ]
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Knee Society Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Oxford Knee Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]
A patient reported questionnaire for assessing the outcome of knee surgery.
Complications [ Time Frame: 4-6 week ] [ Designated as safety issue: Yes ]
The number and type of adverse events will be monitored to assess safety.
Radiographic flexion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Radiographic flexion [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs.
Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
A standard clinical evaluation system for reporting results for patients undergoing total knee replacement.
Oxford Knee Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
A patient reported questionnaire for assessing the outcome of knee surgery.
Complications [ Time Frame: 4-6 months ] [ Designated as safety issue: Yes ]
The number and type of adverse events will be monitored to assess safety.
Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The number and type of adverse events will be monitored to assess safety.
Complications [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
The number and type of adverse events will be monitored to assess safety.

Enrollment:	142
Study Start Date:	August 2007
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rotating Platform High-Flex Cruciate Substituting TKA	Device: Rotating Platform High-Flex Cruciate Substituting TKA
Rotating Platform Cruciate Substituting TKA	Device: Rotating Platform Cruciate Substituting TKA

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176292

Sponsors and Collaborators

Anderson Orthopaedic Research Institute

DePuy Orthopaedics

Investigators

Principal Investigator:

William G Hamilton, MD

Anderson Orthopaedic Research Institute

More Information

No publications provided

Responsible Party:	William Hamilton, MD, Principal Investigator, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:	NCT01176292 History of Changes
Other Study ID Numbers:	AORI2010-0104
Study First Received:	July 26, 2010
Last Updated:	July 30, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:

total knee replacement
high flexion
range of motion
rotating platform
TKA

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis

Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013