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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02279277
Other study ID # Austin2014
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 6, 2014
Last updated October 28, 2014
Start date October 2014

Study information

Verified date October 2014
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 148
Est. completion date
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Knee osteoarthritis (Kellgren-Lawrence grade 3 or 4) confirmed via standing AP radiograph

2. 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

3. Prior knee surgery from arthroscopies, meniscal surgery and ligament reconstruction

Exclusion Criteria:

1. Anyone who received physical therapy in the last 6 months

2. Inability to walk unaided for >1 block

3. Currently engaged in regular PT or a regular home exercise program

4. Prior knee arthroplasty

5. Prior knee surgery for trauma, tumor and osteotomy

6. Injection given within 6 weeks of starting therapy

7. Patients using daily narcotic medications within prior 6 weeks

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion following Total Knee Replacement 6 weeks No
Secondary Patient reported perception of pain following total knee replacement 6 weeks No
Secondary Return to functional activities following total knee replacement 6 weeks No
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