Prospective Functional Outcome Study of the Knee | NCT02079493

Studies
Prospective Functional Outcome Study of the Knee

NCT02079493

Sponsor

Tufts Medical Center

Status

Terminated

Last Update Posted

Aug 28, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Osteoarthritis of the Knee

Interventions

Total Knee Arthroplasty

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not enough subject enrollment

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Feb 24, 2014

First Submission Date that Met QC Criteria

Mar 3, 2014

First Posted Date

Mar 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2019

Last Update Posted Date

Aug 28, 2019Actual

Name	Class
Restor3D	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to obtain patient-oriented and clinically-oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty .

Detailed Description

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term postoperative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness, and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Total Knee Arthroplasty patients		TKA patients	Device: Total Knee Arthroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Total Knee Arthroplasty	Device	Knee replacement	Total Knee Arthroplasty patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Functional testing	Assess patient functional outcomes	6 weeks post-op
Functional testing	Assess patient functional outcomes	6 months post-op
Functional testing	Assess patient functional outcomes	1-year post-op

Secondary Outcomes

Measure	Description	Time Frame
Outcome questionnaires	to assess knee pain and function	6-weeks post-op
Outcome questionnaires	to assess knee pain and function	6-months post-op

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is a male or non-pregnant female age 18 years or older at time of study
Patient is a candidate for a total knee arthroplasty
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

Patients younger than 18 years of age
Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopaedic surgeon
Patients who have had any previous lower extremity procedure
Patients with a BMI greater than or equal to 40
Patients with an active infection within the affected knee joint Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
Patient is diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's Disease)
Patient is immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
Patient has a known sensitivity to device materials
Non-English speaking patients
Patient is a prisoner

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Total knee arthroplasty patients

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Eric L Smith, MD	Tufts Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Tufts Medical Center		Boston	Massachusetts	02111	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Due to PI moving locations and site closing out study, not all follow-up data will be collected and results will not be analyzed

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019645	Arthroplasty, Replacement, Knee

Ancestor Terms

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided