CARTICEL Rehabilitation guidelines

The ultimate success of a CARTICEL procedure is as dependent on rehabilitation as it is on surgical technique. Work closely with your patient to develop an individualized rehabilitation and physical therapy plan, based on the size, location and severity of the cartilage injury.

Complete CARTICEL rehabilitation guidelines

Phase I: Protection (weeks 0-6)
During this first phase, CARTICEL
begins to fill the injured area with
a soft repair tissue and it is critical
that the area be protected.

Phase II: Transition (weeks 6-12)
The repair tissue is spongy and remains
fairly soft at this point, so protection is still
required. Towards the end of the phase, as
tissue continues to mature, patients typically
are able to bear full weight on their knee and
resume most daily activities.

GOALS

  • Protect healing tissue from
    movement and weight
  • Decrease pain and swelling
  • Gradually improve knee’s ability to flex
    and extend
  • Regain quadriceps control

Example Rehabilitation Activity
Continuous Passive Motion (CPM),
8-12 hours/day, from day 1

Example Functional Activity

  • Body weight should not be placed on the knee
  • for about 1 week following implantation
  • Use of crutches
  • Extended standing should be avoided
  • Gradual return to daily activities as pain
  • and inflammation allow
  • Use of stationary bicycle as range of
  • motion (ROM) allows
  • May begin pool exercises by week 4

GOALS

  • Obtain full ROM
  • Further improve strength and endurance
    of quadriceps and hamstrings
  • Increase endurance of functional activities

Example Rehabilitation Activity
If leg is braced, discontinue by week 6

  • Initiate exercises such as weight shifts,
  • mini squats and toe-calf raises
  • Perform balance drills for leg strengthening
  • Gradually increase time with stationary bicycle
  • at low resistance
  • Initiate treadmill walking program

Example Functional Activity

  • Increase the amount of body weight you
    place on your knee as tolerated
  • Place full body weight on your knee and
    discontinue crutches by weeks 6-9
  • Increase the duration of functional activities
    such as standing and walking as pain and
    swelling diminish

Phase III: Maturation (weeks 12-26)
As the repair tissue becomes firmer
and has a hardness like soft plastic, your patient
will be able to perform more functional
and training activities. You patient will notice
improvements of symptoms and generally
normal motion of the knee.

Phase IV: Active (months 6-18)
During the final phase of your patient's
rehabilitation, the repair tissue reaches
full maturity and its firmness resembles
that of the surrounding cartilage.

GOALS

  • Improve muscular strength and endurance
  • Improve balance and stability
  • Achieve full ROM and functional activities by
    the end of this phase with minimal or no pain
    and swelling

Example Rehabilitation Activity

  • Strength exercises including leg press,
    forward lunges, straight leg raises and hip
    abduction/adduction
  • Stretch quadriceps, hamstrings and calves

Example Functional Activity

  • Bicycle
  • Stair machine
  • Swimming and pool exercises
  • Ski machine/elliptical trainer
  • Increase walking in terms of distance,
    cadence, incline, etc., as tolerated

GOALS

  • Gradual return to full unrestricted
    functional activities

Example Functional Activity

  • Return to low-impact sports such as
    swimming, skating, in-line skating and
    cycling at month 6
  • Return to higher-impact sports such
    as jogging, running and aerobics at
    months 8-9 for small lesions or
    months 9-12 for larger lesions
  • Return to high-impact sports such
    as tennis, basketball, football and
    baseball at months 12-18

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Important Safety Information

CARTICEL is for autologous use and is indicated for the repair of symptomatic, cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

For more information on CARTICEL, please see the Package Insert (PDF).