Anatomic Reconstruction of the Patellofemoral Joint

Knee Replacement Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375231
• Other study ID #: 10019
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2011
• Last updated: June 26, 2014
• Start date: June 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: OrthoCarolina Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Replacement Surgery

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	OrthoCarolina Research Institute/OrthoCarolina	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OrthoCarolina Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior knee Pain	Measured by visual analog scale	1 year postoperatively	No
Secondary	Knee Injury and Osteoarthritis Outcome Score (KOOS)	Measure patient reported pain, symptoms, activity of daily living, sport and recreation function and knee related quality of life	1 year postoperative	No
Secondary	Range of Motion of knee		1 year postoperative	No