NCT02279277

Brief Summary

In this study, the investigators are investigating the effects of physical therapy (PT) for treating high grade knee osteoarthritis (OA) in patients that are candidates for total knee replacement. Through the examination of patient outcomes, such as pain, stiffness, and physical function, the investigators will determine if PT prior to total knee replacement is an effective treatment in a patient with high grade OA.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

October 31, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

October 6, 2014

Last Update Submit

October 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Range of Motion following Total Knee Replacement

    6 weeks

Secondary Outcomes (2)

  • Patient reported perception of pain following total knee replacement

    6 weeks

  • Return to functional activities following total knee replacement

    6 weeks

Study Arms (2)

No physical therapy

NO INTERVENTION

No prescribed, supervised physical therapy prior to total knee replacement

Physical Therapy

ACTIVE COMPARATOR

Prescribed, supervised physical therapy prior to total knee replacement

Behavioral: Supervised physical therapy program prior to total knee replacement surgery

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph
  • Surgical candidate for TKA, having had a least a 3 months of pain affecting ADL's unresponsive to conservative treatment consisting of AT LEAST one non-narcotic medication AND one injection (corticosteroid or series of viscosupplementation). Injection must not have been administered within 6 weeks of start of PT trial
  • Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

You may not qualify if:

  • Anyone who received physical therapy in the last 6 months
  • Inability to walk unaided for \>1 block
  • Currently engaged in regular PT or a regular home exercise program
  • Prior knee arthroplasty
  • Prior knee surgery for trauma, tumor and osteotomy
  • Injection given within 6 weeks of starting therapy
  • Patients using daily narcotic medications within prior 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 31, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Last Updated

October 31, 2014

Record last verified: 2014-10