Anatomic Reconstruction of the Patellofemoral Joint

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01375231
First received: June 15, 2011
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Knee Replacement Surgery
Procedure: Measured Resection of patellofemoral joint
Procedure: Measured resection of patella
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain

Resource links provided by NLM:


Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Anterior knee Pain [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
    Measured by visual analog scale


Secondary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]
    Measure patient reported pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life

  • Range of Motion of knee [ Time Frame: 1 year postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: June 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Procedure: 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
Active Comparator: 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.
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375231

Locations
United States, North Carolina
OrthoCarolina Research Institute/OrthoCarolina
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Principal Investigator: Thomas Fehring, MD OrthoCarolina Research Institute, Inc.
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01375231     History of Changes
Other Study ID Numbers: 10019
Study First Received: June 15, 2011
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 22, 2014