Anatomic Reconstruction of the Patellofemoral Joint

Sponsor
OrthoCarolina Research Institute, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT01375231
Collaborator
(none)
52
1
2
23
2.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Measured Resection of patellofemoral joint
  • Procedure: Measured resection of patella
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Anterior knee Pain [1 year postoperatively]

    Measured by visual analog scale

Secondary Outcome Measures

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS) [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 [1 year postoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01375231
Other Study ID Numbers:
  • 10019
First Posted:
Jun 17, 2011
Last Update Posted:
Jun 30, 2014
Last Verified:
Jun 1, 2014

Study Results

No Results Posted as of Jun 30, 2014