NCT00566826

Brief Summary

Knee osteoarthritis is one of the most common causes of disability in older adults. Total knee replacement (TRK) surgery is often an effective solution when persistent pain does not sufficiently improve with non-surgical treatment. Although most TKR surgeries are a success, an estimated 15% to 30% of patients report no clinically significant improvement in function 12 months after a TKR. This study will evaluate the effectiveness of a patient support program in increasing physical function after a TKR surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

September 6, 2023

Status Verified

August 1, 2023

Enrollment Period

4.2 years

First QC Date

November 30, 2007

Last Update Submit

August 31, 2023

Conditions

OsteoarthritisArthroplasty, Replacement, Knee

Keywords

Physical FunctionTotal Knee ReplacementPhysical ActivityBehavioral SupportArthroplastyFunctionSelf-Care

Outcome Measures

Primary Outcomes (1)

  • Physical function (SF36, WOMAC)

    Measured at Months 6 and 12

Secondary Outcomes (1)

  • Physical activity and exercise

    Measured at Months 6 and 12

Study Arms (2)

1

EXPERIMENTAL

Patient support treatment sessions

Behavioral: Patient support sessions

2

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

Interventions

Patient support sessionsBEHAVIORAL

Patient support sessions aim to enhance patient self-care for independent exercise and physical activity.

1
Treatment as usualBEHAVIORAL

Treatment as usual includes standard care for TKR surgery rehabilitation.

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for TKR surgery with one of University of Massachusetts Memorial Health Center's surgeons prior to study entry

You may not qualify if:

  • TKR due to fracture, malignancy, infection, or failure of a previous knee replacement surgery
  • Inability to return home during the rehabilitation period
  • Co-existing conditions that would negate functional improvement with surgery and exercise
  • TKR surgery scheduled on an emergency basis
  • Scheduled for TKR surgeries of both knees at the same time
  • Terminal illness with a life expectancy of less than 1 year
  • Inability to provide informed consent due to dementia or cognitive impairment
  • Planning another TKR or THR surgery within 6 months of study entry
  • Unavailable to complete study procedures (i.e., will be out of the region during the rehabilitation period)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Memorial Health Center; Arthritis and Total Joint Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

  • Ayers DC, Li W, Oatis C, Rosal MC, Franklin PD. Patient-reported outcomes after total knee replacement vary on the basis of preoperative coexisting disease in the lumbar spine and other nonoperatively treated joints: the need for a musculoskeletal comorbidity index. J Bone Joint Surg Am. 2013 Oct 16;95(20):1833-7. doi: 10.2106/JBJS.L.01007.

    PMID: 24132356RESULT

  • Zheng H, Rosal MC, Li W, Borg A, Yang W, Ayers DC, Franklin PD. A Web-Based Treatment Decision Support Tool for Patients With Advanced Knee Arthritis: Evaluation of User Interface and Content Design. JMIR Hum Factors. 2018 Apr 30;5(2):e17. doi: 10.2196/humanfactors.8568.

    PMID: 29712620RESULT

  • Oatis CA, Johnson JK, DeWan T, Donahue K, Li W, Franklin PD. Characteristics of Usual Physical Therapy Post-Total Knee Replacement and Their Associations With Functional Outcomes. Arthritis Care Res (Hoboken). 2019 Sep;71(9):1171-1177. doi: 10.1002/acr.23761.

    PMID: 30281207DERIVED

  • Rosal MC, Ayers D, Li W, Oatis C, Borg A, Zheng H, Franklin P. A randomized clinical trial of a peri-operative behavioral intervention to improve physical activity adherence and functional outcomes following total knee replacement. BMC Musculoskelet Disord. 2011 Oct 7;12:226. doi: 10.1186/1471-2474-12-226.

    PMID: 21981909DERIVED

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Patricia D. Franklin, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

  • Milagros C. Rosal, PhD

    University of Massachusetts, Worcester

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

June 1, 2008

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

September 6, 2023

Record last verified: 2023-08

Locations

US(1)