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.
Please contact your Genzyme Biosurgery Representative for the full 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. 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
MILESTONES TO WORK TOWARDS
- 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
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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
- 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
MILESTONES TO WORK TOWARDS
- 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
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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. 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
MILESTONES TO WORK TOWARDS
- Bicycle
- Stair machine
- Swimming and pool exercises
- Ski machine/elliptical trainer
- Increase walking in terms of distance,
cadence, incline, etc., as tolerated
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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
- Gradual return to full functional activities as
progression in rehabilitation and cartilage healing allows.
MILESTONES TO WORK TOWARDS - 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 Note: Individual results may vary. Many patients are able to participate in sports with some limitations.
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Indications and Usage
Carticel® (autologous cultured chondrocytes) is an autologous cellular product 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.
CARTICEL is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis.
CARTICEL is not recommended for patients with total meniscectomy unless surgically reconstructed prior to or concurrent with CARTICEL implantation.
Important Safety Information
CARTICEL should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin.
It should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb.
Pre-existing conditions, including meniscal tears, joint instability, or malalignment should be assessed and treated prior to or concurrent with CARTICEL implantation.
CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL.
Use of CARTICEL 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).