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Anatomic Reconstruction of the Patellofemoral Joint

NCT ID: NCT01375231

Last Updated: 2014-06-30

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-05-31

Brief Summary

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The investigators posit that it would be advantageous to reproduce the height of the entire patellofemoral joint in order to maintain the lever arm of the quadriceps mechanism at its preoperative level. Failure to do this may cause the quadriceps mechanism to be inefficient. For example the quadriceps mechanism would have to work harder if the total patellofemoral (PF) height is diminished. Alternatively, diminished motion or increased patellar strain may occur if the overall PF height is increased. The investigators theorize that either of these sizing errors could lead to anterior knee pain. The purpose of this study is to compare the clinical outcomes between two surgical techniques: 1) a technique of reproducing the total PF joint on both sides of the articulation (Group 1) and 2) the traditional technique of reproducing only the patellar thickness on one side of the joint (Group 2).

Detailed Description

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There is no consensus on the source of the anterior pain or the most efficacious treatment. Multiple etiologies have been theorized concerning the cause of this problem including tibiofemoral instability, patellofemoral (PF) instability, PF maltracking and patella stress fractures. It has been reported that patellofemoral forces are associated with anterior knee pain. Moreover, it has been reported that a correlation exists between the tension of the quadriceps muscle and the forces on the patella. In a biomechanical, cadaver study, Browne et al. found that a longer extensor moment arm reduced the tension on the quadriceps and reduced the patellar forces.

Conditions

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Knee Replacement Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Measured Resection of patellofemoral joint

The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated

Group Type ACTIVE_COMPARATOR

Measured Resection of patellofemoral joint

Intervention Type PROCEDURE

The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated

Measured resection of patella

The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only.

Group Type ACTIVE_COMPARATOR

Measured resection of patella

Intervention Type PROCEDURE

The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only.

Interventions

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Measured Resection of patellofemoral joint

The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated

Intervention Type PROCEDURE

Measured resection of patella

The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients presenting for a primary total knee replacement who have failed conservative medical management.
2. Total knee replacement includes patella resurfacing.
3. Patient is willing and able to understand, sign, and date the study specific patient informed consent, to volunteer participation in the study.
4. Patient is psychosocially, mentally, and physically able to comply with the requirements of the study including post-op clinical evaluations and completion of questionnaires.

Exclusion Criteria

1. Patients presenting for a unicompartmental knee replacement.
2. Patients presenting for a revision total knee replacement.
3. Total knee replacement does not include patella resurfacing.
4. Patients with angular deformity greater than 15 degrees.
5. Patients with subluxation/dislocation of the patella.
6. Patients with severe patellar bone loss.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Fehring, MD

Role: PRINCIPAL_INVESTIGATOR

OrthoCarolina Research Institute, Inc.

Locations

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OrthoCarolina Research Institute/OrthoCarolina

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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10019

Identifier Type: -

Identifier Source: org_study_id