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20.50 Only OTS Solution
                    to Patellofemoral Pain
Vague anterior knee pain is a very common patient complaint. It affects some 2.5
million Americans annually and is one of the largest and most challenging complaints
physicians hear. Patellofemoral Pain Syndrome is now recognized to encompass a
large disparate group of medical conditions that cause pain at the front of the knee.
The patient profile is predominantly weighted women and young girls. The insurance
                          trend is moving towards off-the-shelf bracing.


                           Form Follows Flexion
                           The most common bracing solution to anterior knee pain is a
                           soft sleeve. These use one of several buttress designs to put
                           pressure on the patella. As the leg goes into extension, these
                           buttresses exert pressure to keep the patella in the patellar
                           groove. But patients are experiencing insufficient relief from
                           the soft braces. Soft Braces do not provide the lateral strength
to resist the quad. Hinged soft knee braces provide greater lateral strength, but still not
sufficient to resist the muscle group with patellofemoral problems. The biggest issue is
the disrupted movement of the patella gliding into the femoral groove. In normal
patellofemoral articulation, the patella is in contact with the femur between 20 and 50
degrees flexion.

As the only patellofemoral brace functioning at 20 – 50 degrees flexion, the 20.50
Patellofemoral Brace:

              Improves patellofemoral tracking
              Controls patellar subluxation and dislocation

Traditional soft sleeve braces have little impact on the patella at the point in time where
they could alter the tracking. Additionally, the brace must be rigid enough to act as a
strong, stable foundation to counter the lateral force of the quadriceps. This requires a
rigid brace and dynamic action that adapts to the increasing pressure. The rigid shell
performance of the 20.50 Patellofemoral Brace counters the force of the quads and
resists rotation.

         Bledsoe is the only manufacturer making a rigid frame
        off-the-shelf patellofemoral brace that functions in flexion.

This is a doubly nice distinction for us as it is the only off-the-shelf brace on the market
and an off-the-shelf brace can be stock and bill while a custom brace cannot. Our
competitor’s are offering only custom rigid frames.

                                        Page 1 of 7
Defining the Pain
Patellofemoral pain syndrome can be defined as retropatellar or peripatellar pain
resulting from physical and biochemical changes in the patellofemoral joint. It should
be distinguished from chondromalacia, which is actual fraying and damage to the
underlying patellar cartilage. Patients with patellofemoral pain syndrome have anterior
knee pain that typically occurs with activity and often worsens when they are
descending steps or hills. It can also be triggered by prolonged sitting. One or both
knees can be affected.

The patella (kneecap) is the moveable bone on the front of the knee. The patella
articulates with the patellofemoral groove in the femur. Several forces act on the
patella to provide stability and keep it tracking properly.

                                          This unique bone is wrapped inside a tendon
                                          that connects the large muscles on the front of
                                          the thigh, the quadriceps muscles, to the lower
                                          leg bone. The large quadriceps tendon together
                                          with the patella is called the quadriceps
                                          mechanism. Though we think of it as a single
                                          device, the quadriceps mechanism has two
                                          separate tendons, the quadriceps tendon on top
of the patella and the patellar tendon below the patella.

Tightening up the quadriceps muscles places a pull on the tendons of the quadriceps
mechanism. This action causes the knee to
straighten. The patella acts like a fulcrum to
increase the force of the quadriceps muscles.

The underside of the patella is covered with
articular cartilage, the smooth, slippery covering
found on joint surfaces. This covering helps the
patella glide (or track) in a special groove made by
the thighbone, or femur. This groove is called the
femoral groove.

Two muscles of the thigh attach to the patella and
help control its position in the femoral groove as
the leg straightens. These muscles are the Vastus
Medialis Obliquus (VMO) and the Vastus Lateralis
(VL). The VMO runs along the inside of the thigh,
and the VL lies along the outside of the thigh. If the
timing between these two muscles is off, the patella
may be pulled off track.




                                        Page 2 of 7
A common misconception is that the patella only moves in an up-and-down direction.
In fact, it also tilts and rotates, so there are various points of contact between the
undersurface of the patella and the femur.


 Causes of Patellofemoral Pain Syndrome

Managing patellofemoral pain syndrome is a challenge, in part because of lack of
consensus regarding its cause and treatment.

Overuse and overload of the patellofemoral joint
Because bending the knee increases the pressure between the patella and its various
points of contact with the femur, patellofemoral pain syndrome is often classified as an
overuse injury. However, a more appropriate term may be "overload," because the
syndrome can also affect inactive patients. Repeated weight-bearing impact may be a
contributing factor, particularly in runners. Steps, hills and uneven surfaces tend to
exacerbate patellofemoral pain. Once the syndrome has developed, even prolonged
sitting can be painful ("movie-goer's sign") because of the extra pressure between the
patella and the femur during knee flexion.

Biomechanical Problems
Pes Planus (Pronation). The
terms "flat feet" and "foot
pronation" are often used
interchangeably. Technically
speaking, foot pronation is a
combination of eversion,
dorsiflexion and abduction of the
foot. This condition often occurs
in patients who lack a supportive          Pes planus, or flat foot (left), in a nonweight-bearing state.
medial arch. Foot pronation                Loss of the medial arch with weight-bearing (right) causes
                                           the ankle to "roll" medially. To compensate, the femur or
causes a compensatory internal             tibia rotates internally, increasing valgus and stressing the
rotation of the tibia or femur             patellofemoral mechanism. Arch supports can help with
(femoral anteversion) that upsets          this problem.
the patellofemoral mechanism. This is the premise behind
using arch supports or custom orthotics in patients with
patellofemoral pain.

Pes Cavus (High-Arched Foot, Supination). Compared with
a normal foot, a high-arched foot provides less cushioning
for the leg when it strikes the ground. This places more
stress on the patellofemoral mechanism, particularly when a
person is running. Proper footwear, such as running shoes
with extra cushioning and an arch support can be helpful.

Q Angle. Although some investigators believe that a "large"
Q angle is a predisposing factor for patellofemoral pain,
                                                                       Q angle. The relevance of this
                                                                       measurement in patients with
                                            Page 3 of 7                patellofemoral pain syndrome
                                                                       has been questioned.
others question this claim. One study found similar Q angles in symptomatic and non-
symptomatic patients.

Another study compared the symptomatic and asymptomatic legs in 40 patients with
unilateral symptoms and found similar Q angles in each leg. Furthermore, "normal" Q
angles vary from 10 to 22 degrees, depending on the study, and measurements of the Q
angle in the same patient vary from physician to physician. Therefore, the physician
should be wary of placing too much emphasis on such biomechanical "variants," as this
can lead patients to believe that nothing can be done about their pain.


Muscular dysfunction
Weakness of the quadriceps muscles is the most often cited area of concern. Other
issues include a muscle imbalance where the quadriceps actually pull the patella out of
the patellar groove, weak quadriceps, hip muscles, calf muscles, hamstrings, or tight
iliotibial bands.



Symptoms
Slipping Sensation
When people have patellofemoral problems, they sometimes report a sensation like the
patella is slipping.

Pain
Others report having pain around the front part of the knee or along the edges of the
kneecap. Typically, people who have patellofemoral problems experience pain when
walking down stairs or hills. Keeping the knee bent for long periods, as in sitting in a
car or movie theater, may cause pain.

“Popcorn”
The knee may grind, or there may be a crunching sound when squatting or going up
and down stairs.




                                       Page 4 of 7
Treatment Options
Non-surgical Treatment
The initial treatment for a patellar problem begins by:
             Decreasing the inflammation in the knee
             Rest and anti-inflammatory medications
             Physical therapy, possibly with ice massage and ultrasound to limit pain
                and swelling
             Bracing or taping the patella to prevent mal-tracking


Surgical Treatment
If non-surgical treatments fail to improve the condition, surgery may be suggested.

       Lateral Release
       The doctor will cut little slits in the lateral muscles to decrease the lateral pull.

       Proximal Realighment
       The doctor will advance the Vastus Medialus Oblique (VMO) muscle over the
       patella to increase the medial pull.

       Distal Realignment
       The doctor will detach the Patella Tuberosity (connecting part for the quad
       muscle and reattach the bone in an area they think will correct the Q angle.

Sometimes the doctor will do all three at once.




                                        Page 5 of 7
The 20.50 Patellofemoral brace offers several innovations:
            First rigid off-the-shelf patellofemoral brace
               on the market
            Patello-Force™ strap promotes natural patella
               movement including tilt and rotation
            Magnesium frame adds stable foundation for
               Patellofemoral as well as MCL and LCL support
            Shortest brace in this market
            Made of high strength magnesium alloy and
               weighs a mere 12 -13 ounces
            Crescent Finger™ Pad grips the patella to
               control Medial Tilt, Patellar Baja and other
               forces
            Corrects high Q-Angle lateral pull

The strapping has a unique look and function to:
             Effectively control mal-tracking
             Counter high Q-angle pull
             Allow appropriate movement on the knee including tilt and rotation



Due to the short frame, the brace sits above the calf muscle belly, unlike other braces in this
market. Therefore, the tibial shell is one size smaller than the femoral shell in the standard
black off-the-shelf version. The 20.50 is also available in a custom version.

Off-the-Shelf price is $ 399                 Custom price is $ 599
Lcode: L1845                                 Lcode: L1846

Satisfies patella tracking add-on code L2800 (Custom) or L2795 (OTS).


Size       Thigh                      Calf                    Left              Right

                   34.3 – 40.6 cm        27.9 – 31.7 cm
   XS                                                                PF010101       PF010201
                    13.5” -16.0”          11.0” – 12.5”

                   40.6 – 47.6 cm        31.7 – 35.6 cm
       S                                                             PF010103       PF010203
                   16.0” – 18.75”         12.5” – 14.0”

                   47.6 – 54.6 cm        35.6 – 39.4 cm
       M                                                             PF010105       PF010205
                   18.75” – 21.5”         14.0” – 15.5”

                   54.6 – 61.6 cm        39.4 – 43.2 cm
       L                                                             PF010107       PF010207
                   21.5” – 24.25”         15.5” – 17.0”

                   61.6 – 68.6 cm        43.2 – 47.0 cm
   XL                                                                PF010109       PF010209
                   24.25” – 27.0”         17.0” – 18.5”

                   68.6 – 74.9 cm        47.0 – 50.8 cm
   XXL                                                               PF010111       PF010211
                    27.0” – 29.5”         18.5” – 20.0”




                                         Page 6 of 7
Accessories

The replacement pad kit consists of:
          Femoral pad
          Tibial pad
          Regular strap pad
          Gripper strap pad
          Y-patella pad and air bladder (no pump)
          Patella buttress pad


Size            Left               Right
XS              PF040101           PF040201
S               PF040103           PF040203
                                                     The replacement strap
M               PF040105           PF040205          kit consists of the two
L               PF040107           PF040207          regular straps and the
XL              PF040109           PF040209          two elastic straps. The
XXL             PF040111           PF040211          part numbers are:

Size                   Left
XS                     PF041001
S                      PF041003
M                      PF041005
L                      PF041007
XL                     PF041009
XXL                    PF041011




                                  Page 7 of 7

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2050 profile sheet2

  • 1. 20.50 Only OTS Solution to Patellofemoral Pain Vague anterior knee pain is a very common patient complaint. It affects some 2.5 million Americans annually and is one of the largest and most challenging complaints physicians hear. Patellofemoral Pain Syndrome is now recognized to encompass a large disparate group of medical conditions that cause pain at the front of the knee. The patient profile is predominantly weighted women and young girls. The insurance trend is moving towards off-the-shelf bracing. Form Follows Flexion The most common bracing solution to anterior knee pain is a soft sleeve. These use one of several buttress designs to put pressure on the patella. As the leg goes into extension, these buttresses exert pressure to keep the patella in the patellar groove. But patients are experiencing insufficient relief from the soft braces. Soft Braces do not provide the lateral strength to resist the quad. Hinged soft knee braces provide greater lateral strength, but still not sufficient to resist the muscle group with patellofemoral problems. The biggest issue is the disrupted movement of the patella gliding into the femoral groove. In normal patellofemoral articulation, the patella is in contact with the femur between 20 and 50 degrees flexion. As the only patellofemoral brace functioning at 20 – 50 degrees flexion, the 20.50 Patellofemoral Brace:  Improves patellofemoral tracking  Controls patellar subluxation and dislocation Traditional soft sleeve braces have little impact on the patella at the point in time where they could alter the tracking. Additionally, the brace must be rigid enough to act as a strong, stable foundation to counter the lateral force of the quadriceps. This requires a rigid brace and dynamic action that adapts to the increasing pressure. The rigid shell performance of the 20.50 Patellofemoral Brace counters the force of the quads and resists rotation. Bledsoe is the only manufacturer making a rigid frame off-the-shelf patellofemoral brace that functions in flexion. This is a doubly nice distinction for us as it is the only off-the-shelf brace on the market and an off-the-shelf brace can be stock and bill while a custom brace cannot. Our competitor’s are offering only custom rigid frames. Page 1 of 7
  • 2. Defining the Pain Patellofemoral pain syndrome can be defined as retropatellar or peripatellar pain resulting from physical and biochemical changes in the patellofemoral joint. It should be distinguished from chondromalacia, which is actual fraying and damage to the underlying patellar cartilage. Patients with patellofemoral pain syndrome have anterior knee pain that typically occurs with activity and often worsens when they are descending steps or hills. It can also be triggered by prolonged sitting. One or both knees can be affected. The patella (kneecap) is the moveable bone on the front of the knee. The patella articulates with the patellofemoral groove in the femur. Several forces act on the patella to provide stability and keep it tracking properly. This unique bone is wrapped inside a tendon that connects the large muscles on the front of the thigh, the quadriceps muscles, to the lower leg bone. The large quadriceps tendon together with the patella is called the quadriceps mechanism. Though we think of it as a single device, the quadriceps mechanism has two separate tendons, the quadriceps tendon on top of the patella and the patellar tendon below the patella. Tightening up the quadriceps muscles places a pull on the tendons of the quadriceps mechanism. This action causes the knee to straighten. The patella acts like a fulcrum to increase the force of the quadriceps muscles. The underside of the patella is covered with articular cartilage, the smooth, slippery covering found on joint surfaces. This covering helps the patella glide (or track) in a special groove made by the thighbone, or femur. This groove is called the femoral groove. Two muscles of the thigh attach to the patella and help control its position in the femoral groove as the leg straightens. These muscles are the Vastus Medialis Obliquus (VMO) and the Vastus Lateralis (VL). The VMO runs along the inside of the thigh, and the VL lies along the outside of the thigh. If the timing between these two muscles is off, the patella may be pulled off track. Page 2 of 7
  • 3. A common misconception is that the patella only moves in an up-and-down direction. In fact, it also tilts and rotates, so there are various points of contact between the undersurface of the patella and the femur. Causes of Patellofemoral Pain Syndrome Managing patellofemoral pain syndrome is a challenge, in part because of lack of consensus regarding its cause and treatment. Overuse and overload of the patellofemoral joint Because bending the knee increases the pressure between the patella and its various points of contact with the femur, patellofemoral pain syndrome is often classified as an overuse injury. However, a more appropriate term may be "overload," because the syndrome can also affect inactive patients. Repeated weight-bearing impact may be a contributing factor, particularly in runners. Steps, hills and uneven surfaces tend to exacerbate patellofemoral pain. Once the syndrome has developed, even prolonged sitting can be painful ("movie-goer's sign") because of the extra pressure between the patella and the femur during knee flexion. Biomechanical Problems Pes Planus (Pronation). The terms "flat feet" and "foot pronation" are often used interchangeably. Technically speaking, foot pronation is a combination of eversion, dorsiflexion and abduction of the foot. This condition often occurs in patients who lack a supportive Pes planus, or flat foot (left), in a nonweight-bearing state. medial arch. Foot pronation Loss of the medial arch with weight-bearing (right) causes the ankle to "roll" medially. To compensate, the femur or causes a compensatory internal tibia rotates internally, increasing valgus and stressing the rotation of the tibia or femur patellofemoral mechanism. Arch supports can help with (femoral anteversion) that upsets this problem. the patellofemoral mechanism. This is the premise behind using arch supports or custom orthotics in patients with patellofemoral pain. Pes Cavus (High-Arched Foot, Supination). Compared with a normal foot, a high-arched foot provides less cushioning for the leg when it strikes the ground. This places more stress on the patellofemoral mechanism, particularly when a person is running. Proper footwear, such as running shoes with extra cushioning and an arch support can be helpful. Q Angle. Although some investigators believe that a "large" Q angle is a predisposing factor for patellofemoral pain, Q angle. The relevance of this measurement in patients with Page 3 of 7 patellofemoral pain syndrome has been questioned.
  • 4. others question this claim. One study found similar Q angles in symptomatic and non- symptomatic patients. Another study compared the symptomatic and asymptomatic legs in 40 patients with unilateral symptoms and found similar Q angles in each leg. Furthermore, "normal" Q angles vary from 10 to 22 degrees, depending on the study, and measurements of the Q angle in the same patient vary from physician to physician. Therefore, the physician should be wary of placing too much emphasis on such biomechanical "variants," as this can lead patients to believe that nothing can be done about their pain. Muscular dysfunction Weakness of the quadriceps muscles is the most often cited area of concern. Other issues include a muscle imbalance where the quadriceps actually pull the patella out of the patellar groove, weak quadriceps, hip muscles, calf muscles, hamstrings, or tight iliotibial bands. Symptoms Slipping Sensation When people have patellofemoral problems, they sometimes report a sensation like the patella is slipping. Pain Others report having pain around the front part of the knee or along the edges of the kneecap. Typically, people who have patellofemoral problems experience pain when walking down stairs or hills. Keeping the knee bent for long periods, as in sitting in a car or movie theater, may cause pain. “Popcorn” The knee may grind, or there may be a crunching sound when squatting or going up and down stairs. Page 4 of 7
  • 5. Treatment Options Non-surgical Treatment The initial treatment for a patellar problem begins by:  Decreasing the inflammation in the knee  Rest and anti-inflammatory medications  Physical therapy, possibly with ice massage and ultrasound to limit pain and swelling  Bracing or taping the patella to prevent mal-tracking Surgical Treatment If non-surgical treatments fail to improve the condition, surgery may be suggested. Lateral Release The doctor will cut little slits in the lateral muscles to decrease the lateral pull. Proximal Realighment The doctor will advance the Vastus Medialus Oblique (VMO) muscle over the patella to increase the medial pull. Distal Realignment The doctor will detach the Patella Tuberosity (connecting part for the quad muscle and reattach the bone in an area they think will correct the Q angle. Sometimes the doctor will do all three at once. Page 5 of 7
  • 6. The 20.50 Patellofemoral brace offers several innovations:  First rigid off-the-shelf patellofemoral brace on the market  Patello-Force™ strap promotes natural patella movement including tilt and rotation  Magnesium frame adds stable foundation for Patellofemoral as well as MCL and LCL support  Shortest brace in this market  Made of high strength magnesium alloy and weighs a mere 12 -13 ounces  Crescent Finger™ Pad grips the patella to control Medial Tilt, Patellar Baja and other forces  Corrects high Q-Angle lateral pull The strapping has a unique look and function to:  Effectively control mal-tracking  Counter high Q-angle pull  Allow appropriate movement on the knee including tilt and rotation Due to the short frame, the brace sits above the calf muscle belly, unlike other braces in this market. Therefore, the tibial shell is one size smaller than the femoral shell in the standard black off-the-shelf version. The 20.50 is also available in a custom version. Off-the-Shelf price is $ 399 Custom price is $ 599 Lcode: L1845 Lcode: L1846 Satisfies patella tracking add-on code L2800 (Custom) or L2795 (OTS). Size Thigh Calf Left Right 34.3 – 40.6 cm 27.9 – 31.7 cm XS PF010101 PF010201 13.5” -16.0” 11.0” – 12.5” 40.6 – 47.6 cm 31.7 – 35.6 cm S PF010103 PF010203 16.0” – 18.75” 12.5” – 14.0” 47.6 – 54.6 cm 35.6 – 39.4 cm M PF010105 PF010205 18.75” – 21.5” 14.0” – 15.5” 54.6 – 61.6 cm 39.4 – 43.2 cm L PF010107 PF010207 21.5” – 24.25” 15.5” – 17.0” 61.6 – 68.6 cm 43.2 – 47.0 cm XL PF010109 PF010209 24.25” – 27.0” 17.0” – 18.5” 68.6 – 74.9 cm 47.0 – 50.8 cm XXL PF010111 PF010211 27.0” – 29.5” 18.5” – 20.0” Page 6 of 7
  • 7. Accessories The replacement pad kit consists of:  Femoral pad  Tibial pad  Regular strap pad  Gripper strap pad  Y-patella pad and air bladder (no pump)  Patella buttress pad Size Left Right XS PF040101 PF040201 S PF040103 PF040203 The replacement strap M PF040105 PF040205 kit consists of the two L PF040107 PF040207 regular straps and the XL PF040109 PF040209 two elastic straps. The XXL PF040111 PF040211 part numbers are: Size Left XS PF041001 S PF041003 M PF041005 L PF041007 XL PF041009 XXL PF041011 Page 7 of 7