Frequently Asked Questions
- What is the CONSERVE® PLUS Total Resurfacing Hip System?
- What is the purpose of the CONSERVE® PLUS Total Resurfacing Hip System? (Indications for use)
- When should the CONSERVE® PLUS device not be used? (Contraindications)
- What are some of the potential benefits of the CONSERVE® PLUS device?
- What are some of the potential risks of the CONSERVE® PLUS device?
- What do the Clinical Studies Show?
- What can you do before your surgery?
- How is hip resurfacing performed?
- What can you expect after your operation?
- What problems may occur during surgery, shortly after surgery, or later on?
- What are some symptoms that would prompt a call to your surgeon after your operation?
- What are some warnings or precautions that you should know about after your operation?
- What can you do to improve your recovery?
- Are there instructions for when you travel?
- What alternatives do you have?
What is the CONSERVE® PLUS Total Resurfacing Hip System?
The CONSERVE® PLUS Total Resurfacing Hip System is composed of the following parts: the CONSERVE® PLUS Acetabular Shell and the CONSERVE® PLUS Femoral Component. Both parts are available in many different sizes.
- CONSERVE® PLUS Femoral Component: The femoral component replaces a portion of the ball-shaped bone at the top of your thigh (femoral head) and has a small stem that is inserted into the top of your thighbone (femur). The femoral component is attached to your thighbone (femur) with bone cement.
- CONSERVE® PLUS Acetabular Shell: The shell replaces the damaged surface of your hip socket (acetabulum) and is attached initially by an interference fit (press-fit) and over time by tissue and/or bone growth (biological fixation) into the shell's outer porous coating.
The femoral component moves within the cup. The surfaces that rub against each other are made from highly polished metal. This type of hip device is called a metal-on-metal hip resurfacing device.
What is the purpose of the CONSERVE® PLUS Total Resurfacing Hip System? (Indications for use)
The CONSERVE® PLUS Total Resurfacing Hip System relieves hip pain and improves hip function by replacing the parts of your hip that have been severely damaged by degenerative joint diseases. These diseases include: osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, and avascular necrosis.The CONSERVE® PLUS Total Resurfacing Hip System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.
When should the CONSERVE® PLUS device not be used? (Contraindications)
You should not receive the CONSERVE® PLUS Total Resurfacing Hip device if:
- You have an infection of the body or blood.
- Your bones are not yet fully grown.
- Your bones are not strong enough or healthy enough because:
- You have severe bone loss (osteoporosis) or have a family history of severe bone loss.
- You have bone loss (such as avascular necrosis) affecting more than half of your femoral head.
- You have multiple fluid-filled cavities (cysts) greater than 1 centimeter in your femoral head.
- A test (such as DEXA scan) may be needed to determine your level of bone loss.
- You have any blood vessel-related disease, muscle-related disease, or nerve-and muscle-related disease that may prevent the artificial hip joint device from remaining stable or that may prevent you from following instructions during the recovery period.
- You are a female of child-bearing age. It is unknown whether metal ions released by the device could harm an unborn child.
- Your kidneys are not working very well (function is significantly impaired). You will need testing (creatinine, GFR, BUN) before and/or after surgery to test your kidneys.
- You have a suppressed immune system due to diseases, such as AIDS, or are receiving high doses of corticosteroids.
- You are severely overweight.
- If you have had reactions to wearing metal jewelry, you may have what is called "metal sensitivity".
Your doctor will need complete information about your overall health to determine whether the CONSERVE® PLUS Total Resurfacing Hip System is right for you. Inform your doctor about any health problems you have, even if it is not related to your hip, because some medicines as well as diseases (such as diabetes) can affect your kidney or bone strength in the future.
What are some of the potential benefits of the CONSERVE® PLUS device?
Your surgeon has decided that you will benefit from hip replacement surgery. The benefits may include the relief of pain and return of function of the hip. When thinking about the benefits of the CONSERVE® PLUS Total Resurfacing Hip System, you should compare the possible risks and benefits of the CONSERVE® PLUS Total Resurfacing Hip System to the risks and benefits of other types of artificial hip replacement devices:
- Hip resurfacing versus a total hip replacement: The CONSERVE® PLUS Total Resurfacing Hip System is a hip resurfacing device. With a hip resurfacing device, the surgeon covers your hip socket with a metal cup, and covers your femoral head with a metal cap. With a total hip replacement device, the surgeon covers your hip socket with a cup and replaces your femoral head with a metal ball attached to a long metal stem. The metal stem is inserted into your thighbone.
- Metal-on-metal versus metal-on-plastic or ceramic-on-ceramic: With metal-on-metal systems, the cap (ball) and the socket components are made from highly polished metal. The CONSERVE® PLUS Total Resurfacing Hip System is a metal-on-metal system. Other hip systems can have a metal ball with a plastic lined socket (metal-on-plastic) or a ceramic ball with a ceramic lined socket (ceramic-on-ceramic).
Each of the device types discussed above can significantly improve hip pain and function. However, specific potential benefits of the CONSERVE® PLUS Total Resurfacing Hip System include:
- The CONSERVE® PLUS Total Resurfacing Hip System's metal cup will not chip or crack as ceramic components can.
- The CONSERVE® PLUS Total Resurfacing Hip System does not cause thighbone (femoral shaft) fractures as total hip replacement systems can.
- The CONSERVE® PLUS Total Resurfacing Hip System may make future revision surgery easier, should that be required, because hip resurfacing surgery leaves your femoral head in place and there is no large metal stem placed in the thighbone. In contrast, revision surgery of a total hip replacement where your femoral head has been removed and a large stem is in place can be a more difficult operation.
- Dislocation of the ball head from the socket is less common with the CONSERVE® PLUS Total Resurfacing Hip System than with total hip replacement devices. In the clinical study 1.3% of 292 patients treated with the CONSERVE® PLUS Total Resurfacing Hip System experienced hip dislocation while the study ceramic-on-ceramic and metal-on-metal total hip replacement devices had a dislocation rate of 1.5% and 3.1%, respectively. There have been no revisions or removals related to dislocation of the CONSERVE® PLUS Total Resurfacing Hip System.
What are some of the potential risks of theCONSERVE® PLUS device?
The risks and complications associated with the CONSERVE® PLUS Total Resurfacing Hip System are expected to be similar to those of other resurfacing and/or hip replacements.The risks and complications include:
- Excessive bleeding
- Damage of blood vessels may occur due to surgery
- Delayed wound healing
- Sudden drop in blood pressure during surgery due to the use of bone cement or anesthesia
- Temporary or permanent nerve damage
- Allergic reaction due to anesthesia, medication, or device material
- Allergic reaction to the implant's materials. As the parts rub against each other, metal ions are released into the body, which may cause an allergy. There are no known medical consequences of these ions at this time, however, studies are ongoing.
- Infection, which can lead to removal of the device
- The femoral neck may break
- Device loosening from the surrounding bone
- Increase in hip pain and/or reduced function
- Hardening of the tissue (calcifications) or bony points around the devices
- Device related noise such as, clicking, popping, squeaking or grinding
- Ball and socket may separate (hip dislocation)
- Overuse of the device from too much weight or activity may cause the device to fail prematurely
- Change in the length of the treated leg (limb length discrepancy)
- Premature wear or breakage of the implant
- Bone breakage due to osteoporosis or accidents (trauma)
- Damage to the bones and tissue (tissue necrosis, pseudotumor) near the hip joint, including loss of the surrounding bone (osteolysis) or staining of the hip joint fluid (metalosis) due to wearing of the metal parts over time
- Pseudotumor; and
- Chronic inflammatory response due to metal sensitivity (Aseptic Lymphocyte Dominant Vasculitis Associated Lesion - ALVAL)
These potential adverse events may require additional medical and/or surgical procedures and should be discussed with your surgeon. Rarely these complications can lead to death.
What do the Clinical Studies Show?
A clinical study was performed to evaluate the safety and effectiveness of the CONSERVE® PLUS Total Resurfacing Hip System. Clinical trial data was collected on 1366 hips implanted with the CONSERVE® PLUS Total Resurfacing Hip System. Complication (safety) information was collected from this group of 1366 study procedures and, of these, 540 of 680 unilateral, original shell, cases comprised the 24-month safety group. Effectiveness information was collected from the 292 procedures in the Pivotal Unilateral Efficacy Cohort (original shell) and, of these, 264 were rated for pain and function (Harris Hip Score) at 24+ months after surgery.
Safety Data: Complication (safety) information was collected from the entire group of 1366 study procedures and, of these, 540 of 680 unilateral, original shell cases completed the 24-month safety data collection process. Some complications occurred at a higher rate in CONSERVE® PLUS patients versus other hip replacement systems. These complications were:
- Bone formation in surrounding tissue (heterotopic ossification)
- Bruising and swelling (hematoma)
- Infection
- Nerve problem
- Pain
- Wound problems
- Tenderness on the upper, outside portion of the thighbone (trochanteric bursitis)
However, the overall complication rate and types of complications were similar to the types reported for other hip replacement systems. The revision rate between CONSERVE® PLUS patients and other hip replacement systems was also similar. 36 of 540 (6.7%) CONSERVE® PLUS patients required revision surgery. Reasons for revision in these 36 patients were: fracture of the neck of the thigh bone (19), loosening of the implant (6), infection (4), impingement of the implant (2), migration of the implant (1), protrusion of the implant into the wall of the pelvis bone (1), pain (1), and other reasons (2). There were no deaths directly related to the use of the device inthe study.
Effectiveness Data: Effectiveness information was collected from the 292 procedures in the Pivotal Unilateral Efficacy Cohort (original shell) and, of these, 264 were rated for pain and function (Harris Hip Score) at 24+ months after surgery. Harris Hip Total scores were summarized in categories used to summarize clinical outcome. This scoring system is used to tell doctors how well patients are functioning with their hip replacement including their ability to walk (with or without a walking aid), and the patient's level of pain. Refer to Table 1.
What can you do before your surgery?
Your doctor may want you to meet the Physical Therapist (PT) even before the surgery. The PT may give you some tips on preparing your house for rehabilitation and how you should sleep, get out of bed, sit, stand, and walk following surgery. In addition, here are a few simple ideas:
- Rearrange furniture: Rearrange your furniture to create wide traffic paths and remove obstacles. Make it as easy and safe as possible to move around your home during your recovery.
- Buy a firm pillow: Putting a firm pillow on a low chair or sofa before sitting down may help reduce discomfort.
- Remove electrical cords: Remove, hide, or tape the electrical cords to the floor to avoid tripping over them.
- Have an armchair available: During rehabilitation, you may be told to only sit in armchairs as you will need the arms to help you sit downand get up.
- Elevated toilet seat: Arrange to have an elevated toilet seat and / or support bars fitted in your bathroom.
- Pack up the throw rugs: Rugs can shift or bunch, causing you to slip or trip. Don't take chances - remove them before your surgery.
- Stock up on food: It's a good idea to stock up on canned or frozen foods. To avoid bending over or using a stool or step ladder, store all supplies between waist and shoulder level for easy access.
- Prepare a bed downstairs: If your bedroom is upstairs or in the basement, prepare a bed on the ground floor of your home to use temporarily upon your return from the hospital.
- Get help with household chores: For the first few weeks following your surgery, you'll need some help with typical household chores like cooking, cleaning, shopping, bathing, and doing laundry. If you don't have a spouse, relative or friend who can help with these essential tasks, your healthcare team can assist you in making arrangements (in advance) for someone to help you around the home. As an alternative, you can also arrange a short stay at an extended care rehab facility while you recover.
In addition to preparing your home, it is important to be as "fit" and strong as possible before undergoing the CONSERVE® PLUS Total Resurfacing Hip procedure. Strengthening the muscles around your hip and in your legs and arms will help to make recovery progress faster. Talk with your doctor or PT about exercises you can do to prepare for your surgery. Also make sure there are no active infections within your body and stop smoking.
How is hip resurfacing performed?
The CONSERVE® PLUS Total Resurfacing Hip System is similar to a total hip replacement from a surgical perspective.
- Instead of cutting off the arthritic femoral head (top of the thighbone), the head is reshaped and resurfaced with a metal mushroom-shaped cap.
- In the operating room, EKG electrodes will be placed on your chest and side to monitor your heart rhythm during surgery.
- The anesthesiologist will then inject medication through your IV line to put you to sleep (general anesthesia) or block feeling from the waist down (spinal anesthesia).
- Your surgeon makes an incision and exposes the hip joint.
- The hip socket is prepared in a similar fashion to a total hip replacement.
- The diseased cartilage is removed and a CONSERVE® PLUS Acetabular shell is put (press fit) into place.
- In a similar manner, the diseased part of the femur (thighbone) is removed and the CONSERVE® PLUS Femoral component is cemented in place.
The CONSERVE® PLUS Femoral and Acetabular Shell components resurface both moving parts of the hip joint. All components of the CONSERVE® PLUS Total Resurfacing Hip System are made of standard materials that have a long history of use in the human body. The surgery itself generally takes between 1 to 1 ½ hours.
What can you expect after your operation?
Recovery from any operation varies from patient to patient and post-operative rehabilitation programs vary from hospital to hospital and surgeon to surgeon.
After surgery, you will need to rest your hip to allow proper healing. Your activity will be restricted during this healing period. During the first few weeks after surgery, you may be advised to put a pillow between your legs when turning over in bed, wear elastic stockings, use a raised toilet seat, take showers instead of baths, restrict activities such as sudden twisting or turning, crossing legs, and driving. Also, avoid exposing the scar to sunlight for the first 6 months; if the scar is exposed to the sun, sunscreen (SPF 30-45) is recommended.
Follow your surgeon's instructions carefully. Your surgeon will give you detailed post-operative instructions before you leave the hospital. Even after the healing period, excessive loads placed on the implant through sudden trauma or high impact activities, such as running and jumping, can damage the joint. Most hip replacement patients stay in the hospital three to five days.
- The length of your hospital stay will depend on your medical condition and your progress in rehabilitation.
- Your surgeon will decide how much weight you will be able to put on the affected leg and will tell you how active you can be.
- Until your surgeon says to walk on the hip, you must have someone or something (walker) to help aid walking to and from the toilet or other activities; too much motion of the hip may be harmful to the healing process.
- If you are involved in heavy walking, running, lifting, or muscle strain activities, these heavy forces on your body may cause failure of the fixation, the device or both.
- You should not expect the new hip device to restore function to the level of normal healthy bone.
- You will have to visit your surgeon at various times after surgery to check hip pain and function.
- You will have to go for X-rays on a regular basis to detect problems; the X-rays will also check the position of the hip implant and to check the surrounding bones.
It is important to follow your surgeon's instructions carefully so healing from surgery can occur as quickly as possible.Follow-up office visits may include physical therapy, radiologic exams, blood work, and urine analysis.
What problems may occur during surgery, shortly after surgery, or later on?
What complications can happen during or shortly after surgery?
- Pain
- Femoral or acetabular (related to the hip socket) perforation (hole) or broken bones
- Broken bone while seating or implanting the device
- Damage to blood vessels
- Temporary or permanent nerve damage resulting in pain or numbness of the affected limb
- Undesirable shortening or lengthening of the limb caused by improper selection of the implant size
- Traumatic wounds of the hip from positioning of the leg during surgery
- Cardiovascular disorders including blood clots in the veins or lungs, or heart attackv
- Pocket of blood caused by bleeding from a broken blood vessel which appears "black and blue"
- Delayed wound healing
- Infection
What complications can happen later on?
- Pain
- Broken bone by trauma or excessive loading (weight or force), particularly in the presence of poor bone quality
- A small piece of the thigh bone may pull away as a result of excess muscular tension, early weight bearing, or accidental weakening during surgery
- The thigh bone may not heal properly due to weak reattachment and/or early weight bearing
- Problems with either leg because of differences in leg lengths or because of lack of muscle
- Calcium deposits around the joint or bone formation, with or without ability to move the joint
- Inadequate range of motion due to improper selection or positioning of hip parts
- Device related noise such as, clicking, popping, squeaking or grinding
- Wear of metal moving surfaces may result in increased levels of cobalt and chromium metal particles in the body.
Effects and duration of increased metal ion concentrations are not known.
What are some symptoms that would prompt a call to your surgeon after your operation?
- Redness, swelling, or drainage from around the incision
- An unexplained fever (temperature over 100 degrees Fahrenheit or 38 degrees Centigrade) or chills that last more than a day
- Severe hip pain that is not relieved by your pain medicine
- Any unusual shortening or turning of the leg
- Any sudden swelling in the thigh or calf. It will always be important to protect this new part of your body from infection.
WARNING: Always follow your surgeon's directions for activity limitations. Failure to do so may result in damage to your joint and may lead to device failure.
WARNING: Device failure may require additional surgery to remove the device (revision surgery).
WARNING: You should call your surgeon if your hip feels unsteady.
Options you will have if the device needs to be revised: If your CONSERVE® PLUS Total Resurfacing Hip System components need to be revised sometime in the future, the CONSERVE® PLUS Total Resurfacing Hip System may make future revision surgery easier because hip resurfacing surgery leaves your femoral head in place. The revision surgery would be a total hip replacement which uses a large metal stem placed in the thighbone instead of the small mushroom shaped femoral component.
What are some warnings or precautions that you should know about after your operation?
If you ever have any of the following procedures, you will need antibiotics before them to help protect the joint from the possibility of infection:
- Endoscopy of any kind, which includes: cystoscopy, colonoscopy, sigmoidoscopy and bronchoscopy
- Dental work, including teeth cleaning
- Surgery of any kind
- Urinary catheterization
If you have infection in any part of your body, contact your physician.
If a physician prescribes an MRI scan for you, inform the physician that the CONSERVE® PLUS Total Resurfacing Hip System has not been evaluated for safety and compatibility in the MR environment. The CONSERVE® PLUS Total Resurfacing Hip System has not been tested for heating or migration in the MR environment.
What can you do to improve your recovery?
The majority of your therapy and rehabilitation will occur once you have checked out of the hospital. Your Physical Therapist (PT) will design an exercise program to increase the motion and strength of your hip and will teach you the exercises, making sure you know proper form before you begin. Your commitment to the physical therapy program will help your post-operative recovery.
Before you go home, a PT will teach you to climb stairs and transfer from a bed, chair, and car. Your PT may also give you a list of exercises to be performed at home every day. The objective is to become as independent as possible in your personal care and daily activities before you return home.
Take care to protect your joint replacement from unreasonable stresses and to follow your treating physician's instructions regarding activity level. Avoid high impact activities such as running and jumping, particularly during the first post-operative year while the bone is healing. Excessive force on the implant can lead to device failure (breakage or loosening). Artificial joint replacement devices can wear over time and may require replacement.
Please read and comply with the follow-up care and treatment instructions given by the physician. This hip device does not replace normal healthy bone. The hip parts can break or become damaged as a result of strenuous activity, trauma, or even normal use. All implants have a limited expected service life and may need to be replaced at some time in the future.
Are there instructions for when you travel?
After you receive a metal implant, it may activate metal detector alarms. Tell the security officer about your artificial hip when you must pass through metal detectors in airports, stores, and public buildings. Ask your surgeon for a card that shows that you have had a hip replacement and if you should go through the metal detector system.
What alternatives do you have?
Depending on individual circumstances, alternative procedures may include the use of other commercially available total hip replacement parts already approved or cleared by FDA; non-surgical treatment such as reduced activity and/or pain medication; or other surgical treatments that do not involve the use of an implant, such as a hip joint fusion. Additionally, your doctor can recommend non surgical therapy such as weight loss, mild exercise programs, physical therapy, assistive devices (such as canes), and lifestyle modifications.
- Hip resurfacing versus a total hip replacement: With a hip resurfacing device, the surgeon covers your hip socket with a metal cup and covers your femoral head with a metal cap. The CONSERVE® PLUS Total Resurfacing Hip System is a hip resurfacing device. With a total hip replacement device, the surgeon covers your hip socket with a cup and replaces your femoral head with a metal ball attached to a long metal stem. The metal stem is inserted into your thighbone.
- Metal-on-metal versus metal-on-plastic or ceramic-on-ceramic: With metal-on-metal systems, the cap (ball) and the socket components are made from highly polished metal. The CONSERVE® PLUS Total Resurfacing Hip System is a metal-on-metal system. Other hip systems can have a metal ball with a plastic lined socket (metal-on-plastic) or a ceramic ball with a ceramic lined socket (ceramic-on-ceramic).
For additional information on the CONSERVE® PLUS Total Resurfacing Hip System, please review the patient information brochure.
