Clinical trial NCT01375231: Anatomic Reconstruction of the Patellofemoral Joint
Official title: Anatomic Reconstruction of the Patellofemoral Joint: A Solution for Anterior Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Replacement Surgery
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Anterior knee Pain
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 1 year postoperative
measure: Range of Motion of knee
timeFrame: 1 year postoperative
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute/OrthoCarolina
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Thomas Fehring, MD
role: PRINCIPAL_INVESTIGATOR
References: