MedDataX Logo

Physical Therapy Prior to Total Knee Replacement

NCT ID: NCT02279277

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Hip

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No physical therapy

No prescribed, supervised physical therapy prior to total knee replacement

Group Type NO_INTERVENTION

No interventions assigned to this group

Physical Therapy

Prescribed, supervised physical therapy prior to total knee replacement

Group Type ACTIVE_COMPARATOR

Supervised physical therapy program prior to total knee replacement surgery

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Supervised physical therapy program prior to total knee replacement surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Austin2014

Identifier Type: -

Identifier Source: org_study_id