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NCT Number: NCT01375231

Anatomic Reconstruction of the Patellofemoral Joint

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).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

OrthoCarolina Research Institute/OrthoCarolina

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Anterior knee Pain

    Time frame: 1 year postoperatively

    Measured by visual analog scale

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 1 year postoperative

    Measure patient reported pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life

  2. Range of Motion of knee

    Time frame: 1 year postoperative

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 17, 2011
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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