Anatomic Reconstruction of the Patellofemoral Joint

NCT01375231 | Completed Phase 4 DMC

• 1 other identifier: 10019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Knee Replacement Surgery

Outcome Measures

Primary Outcomes (1)

• Anterior knee Pain

  Measured by visual analog scale

  1 year postoperatively

Secondary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  1 year postoperative

• Range of Motion of knee

  1 year postoperative

Study Arms (2)

Measured Resection of patellofemoral joint

ACTIVE COMPARATOR

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

Procedure: Measured Resection of patellofemoral joint

Measured resection of patella

ACTIVE COMPARATOR

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

Procedure: Measured resection of patella

Interventions

Measured Resection of patellofemoral joint 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 patellofemoral joint

Measured resection of patella 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.

Measured resection of patella

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients presenting for a unicompartmental knee replacement.
• Patients presenting for a revision total knee replacement.
• Total knee replacement does not include patella resurfacing.
• Patients with angular deformity greater than 15 degrees.
• Patients with subluxation/dislocation of the patella.
• Patients with severe patellar bone loss.

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute/OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

Study Officials

• Thomas Fehring, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

US (1)