Transforming Amputation Outcomes with Osseointegration Technology

Modern limb salvage surgery has become the standard of care for over 90% of sarcoma patients; however, a subset (around 10%) still requires amputation for either local disease control or palliative care. Sarcoma surgical solutions require a challenging and delicate balance between oncologic control and preservation of function, but recent advancements such as osseointegration offer improved functional outcomes and quality of life for those patients who may necessitate amputation.

While osseointegration is not yet widespread, specialized centers such as Moffitt Cancer Center offer this innovative technology to expand the possibilities for limb preservation and enhanced prosthetics.

Limb Salvage Surgery and Amputation

Sarcoma surgical treatment prioritizes limb preservation through wide resection of the tumor followed by complex reconstruction of the resulting bony defect. This allows most patients to maintain use of their affected limb while removing the local disease. However, when negative margins cannot be achieved, or extensive neurovascular involvement makes resection unfeasible, amputation may be necessary.

Socket prostheses are the traditional rehabilitation approach for patients requiring amputation. An external prosthetic device is attached to the residual limb through a custom-fitted socket. However, they pose significant challenges, especially in high-level amputations. Common complications include recurrent skin infections, limited range of motion, persistent pain, and socket retention issues due to stump volume fluctuations.

These ongoing issues often limit patients, preventing them from returning to baseline activity levels.

Osseointegrated Amputee Technology Advancements

As limb salvage technology has progressed, one significant advancement stands out as an alternative to traditional socket prostheses. First identified in 1962, osseointegration allows the direct skeletal attachment of prosthetic limbs through transdermal implants that integrate with bone tissue.

Initially applied in dental implants and bone-anchored hearing aids, osseointegration has become a promising solution for amputation reconstruction over the past two decades. It has brought new hope to patients who can’t tolerate conventional sockets or amputee patients looking for a better quality of life.

“An amputation is a life-altering event,” said Dr. Alexander Lazarides, an orthopedic surgeon in Moffitt’s Sarcoma Program and one of our on-site experts in limb salvage surgery expert. “For certain patients, traditional socket prosthetics are poorly tolerated. Osseointegration offers an opportunity for improved function and quality of life, with better utilization of prosthetics and a new lease on life. While not appropriate for everyone, in carefully selected patients, this is a truly revolutionary option.”

Osseointegration relies on the ability of certain implant materials to allow bone ingrowth and produce a solid fixation. The procedure is divided into two stages: the initial implant placement, followed by three to six months of healing to allow bone integration, and the abutment attachment, followed by three weeks of healing. Patients then undergo 12 weeks of progressive loading before resuming daily activities with their new prosthesis.

Several osseointegrated implants are currently under development; however, the OPRA™ (Osseointegrated Prostheses for Rehabilitation of Amputees) Implant System is currently the only fully FDA-approved osseointegration implant system for direct attachment of prosthetic limbs.

Clinical outcomes so far have been promising, with one Swedish OPRA study reporting a 92% success rate at five years and sustained benefits at 15 years post-operation. Patients report increased prosthesis wear time, improved function (particularly in above-the-knee amputees), and reduced pain. While low-grade soft-tissue infections remain the most common complication, they are generally manageable.

Currently, osseointegration is only available at select high-volume centers worldwide, such as Moffitt Cancer Center. Recent FDA approval has expanded access to certain implants in the United States, including the OPRA™ Implant System. Questions about long-term durability persist as studies continue to follow up with participants. As we collect more data and focus on advancing these systems with special sensing systems to monitor implant integration, we’re hopeful for continued positive results.

OPRA™ Implant System

The OPRA™ Implant System is the first commercially available and most extensively studied osseointegrated prosthetic system. It uses three components: a fixture (anchoring element), abutment (skin-penetrating connection), and abutment screw. Together, these components enable a direct skeletal attachment of prosthetic limbs for both upper and lower extremities.

Developed through 15 years of research, the system uses an innovative surface material, a porous-coated titanium stem, which promotes bone attachment while preventing fractures.

OPRA™’s key benefits include:

• Elimination of socket-related complications (perspiration, ulcers, skin irritation)
• Improved proprioception (extension of body and mind)
• Increased range of motion
• Simplified prosthetic attachment/detachment
• Greater comfort when sitting
• Allowance of volume fluctuations
• Better patient gait
• More frequent prosthetic use
• Improved quality of life scores

Clinical studies demonstrate that users achieve superior functional mobility outcomes compared to socket prosthesis users.

Limb Salvage Surgery at Moffitt Cancer Center

As one of Florida’s highest-volume sarcoma and orthopedic oncology practices, Moffitt Cancer Center offers comprehensive limb salvage and reconstruction solutions through an experienced multidisciplinary team. Led by specialists like Dr. Lazarides, who focused on custom implant solutions, complex upper extremity tumors and novel therapeutic developments, Moffitt’s surgical team brings extensive experience in complex limb reconstruction and plastic surgery with oncologic reconstruction.

Nearly 12,000 amputations are performed in Florida annually, and Moffitt is one of only three centers in Florida—and the state's only dedicated cancer hospital—offering OPRA osseointegration technology. This exclusive position, combined with Moffitt’s history of surgical innovation (such as with custom implant technology, surgical navigation and complex reconstructions, such as endoprosthetic reverse shoulder technology), makes Moffitt the best place for patients who require complex limb salvage procedures, whether following limb loss from cancer, trauma, or other conditions.

Dr. Lazarides notes, “Osseointegration requires a thoughtful team approach in a patient-centered manner. Patients should look for providers who see them holistically and who work with the patient to achieve their goals. The Moffitt team is well equipped for the multidisciplinary management of these patients and is one of only a handful of centers in the Southeast offering the OPRA osseointegrated technology.”

Healthcare providers seeking optimal outcomes for patients with complex limb reconstruction needs should consider referring them to Moffitt Cancer Center to ensure they have access to the most advanced surgical options and comprehensive approach available.

As one of Florida’s leading sarcoma and orthopedic oncology practices, we welcome your patient referrals to our program. Please complete our online form or contact a physician liaison for assistance. As part of our efforts to shorten referral times as much as possible, online referrals are typically responded to within 24 - 48 hours.