I. Disclaimer

This document is intended to be used as a reference for non-VA providers and not intended to replace clinical judgment when determining care pathways. These guidelines do not guarantee benefits or constitute medical advice.

II. Clinical Determinations and Indications

1. Indications for the OPRA Implant System for Transfemoral Amputations
   The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System for transfemoral amputations is the only FDA-approved osseointegration implant system and is considered medically necessary when ALL the following criteria are met:
   • History of unilateral or bilateral transfemoral amputation due to trauma or cancer 
   • Current or anticipated rehabilitation problems secondary to challenges with wearing a conventional socket prosthesis such as: 
     • Recurrent skin infections and/or ulcerations in the socket contact area 
     • Pain in the socket contact area 
     • A short stump preventing the use of socket prosthesis 
     • Volume fluctuation in the stump 
     • Soft tissue scarring 
     • Extensive (large) area of skin grafting 
     • Socket retention problems due to excessive perspiration 
     • Restricted joint mobility 

2. Limitations/Exclusions
   The OPRA Implant System is not indicated for Veterans with transfemoral amputations if any of the following are applicable:
   • Incomplete bone growth based on x-ray examination
   • Atypical bone anatomy that might affect treatment, including:
     • Bone measurements outside the device’s acceptable interval of measurement
     • Growth and/or development that is not normal
     • Conditions that may prevent the device from being placed correctly, such as deformities, fractures, or infections
   • Implantation would result in less than 2 millimeters (mm) of remaining cortex (outer layer) bone available around the implant
   • Osteoporosis (weak bones)
   • Body weight greater than 220 pounds
   • Pregnant at time of implantation surgery
   • Current use of the following drugs may negatively affect the anchoring of the OPRA device in the femur and cause loosening of the fixture:
     • Steroids for systemic use
     • Chemotherapy agents
   • Presence of one or more of the following pre-existing conditions:
     • Severe peripheral vascular disease
     • Diabetes mellitus with complications
     • Skin disorders involving the residual limb
     • Neuropathy or neuropathic disease and severe phantom pain
     • Active infection or inactive bacteria
     • Metabolic bone disease or metastatic lesions (such as cancer) in the femur
3. For all other conditions and amputation types and levels not listed in section II.a. of this document, the OPRA Implant System is considered not medically necessary due to insufficient evidence of efficacy and safety.

3. Description of Treatment
   The OPRA Implant System is currently the only fully FDA-approved osseointegration implant system for direct skeletal attachment of prosthetic limbs in patients with amputations at the transfemoral level. Osseointegration at all other amputation levels has not yet received full FDA approval.
   
   The OPRA Implant System is an alternative treatment option to traditional socket prosthesis, where the external prosthesis is anchored directly to the patient’s remaining bone through a permanently implanted titanium screw that comes through the skin. Therefore, the prosthesis always attaches correctly, remains firmly in place, and is free from pressure sores, pain, heat, chafing and general discomfort found with traditional solutions.
   
   Two surgeries are needed to install the OPRA Implant System:
   • The goal of the first surgery is to implant the threaded intramedullary bone anchor, a cylindrical-shaped fixture, into the center canal of the remaining thigh bone or residual limb
   • In the second surgery, approximately three to six months later to allow the implant to integrate with the host bone and anchor to one another, an abutment is attached to the implanted fixture, creating a stoma at the skin-implant interface, which will complete the prosthesis connection
     
4. The OPRA Implant System extends through the skin at the bottom of the patient’s remaining limb to connect to the prosthesis. The leg prosthesis is attached to the abutment screw through a quick connection Axor II device. The Axor II is an osseointegrated external prosthetic connection device that provides a standard connection between the OPRA implantable components and other external prosthetic components. In the event of excessive twisting, the Axor II connection device releases the prosthesis to prevent damage to the bone-anchored fixture. During the first stage of rehabilitation, a specially designed training prosthesis is used before moving on to the full-length prosthesis.

III. Background and Supporting Information

The following information is for reference purposes only in accordance with the medical benefits package outlined in 38 C.F.R. § 17.38 (b). Each subsection supports VA’s determinations for medical necessity and alignment with generally accepted standards of medical practice.

1. Background Information
   Osseointegration & Osseointegration for Skeletal Attachment of Prosthetic Limbs
   The term osseointegration refers to a technique where an artificial implant is permanently and surgically anchored and integrated into bone. In this process, bone will eventually grow into the artificial implant to secure the implant in place. This technique is used with both dental implants and joint replacement surgery.
   
   In the use of osseointegration for skeletal attachment of a prosthetic limb, a percutaneous implant system is directly connected to the residual bone following an amputation. The portion of the implant system that extends through the soft tissues and skin is used to connect the implant to the prosthetic limb.
   
   Potential Advantages of Osseointegration
   There are many potential advantages of osseointegration, which include improved mobility and proprioception (a sensory function that allows one to determine position of their body part), reduced nerve pain, and elimination of the common problems associated with the traditional socket prosthesis, like pinching, sweating, poor fit, poor control, skin irritation, and sores. Because the artificial implant is directly connected to the skeletal bone, this technique provides great stability, strength, and energy transfer. Touch vibrations (usually felt during impact with the ground while walking) may be transferred to the natural bone, resulting in the ability to walk more smoothly, feel more stable, and transfer strength from the limb to the prosthesis.
   
   Risks/Complications
   Osseointegration presents the risk of serious complications such as infection, failure of the implant, and bone fracture. Additionally, the osseointegration surgical procedure requires not using a prosthesis for a period of time, along with an extensive rehabilitation period.
   
   Improper use such as failure to follow and complete the required training, excessive physical activity creating an overload on the device, or injuries such as falls will increase the risks.

2. Research, Clinical Trials, and Evidence Summaries
   The modern research literature related to osseointegration spans a period of over 20 years from 2000 to present. The literature in this field has been summarized in seven systematic reviews published between 2015 and 2020. Most studies evaluating the safety and efficacy of osseointegrated implants have been classified as Level III or IV observational studies because they used retrospective or prospective observational cohort designs. Only a few studies have been classified as Level II evidence. Most investigations have utilized a pre-post design with subjects serving as their own controls while a few have utilized a separate control group using socket-based prosthetic limbs. Due to the inability to blind either subjects or investigators from the intervention, no formal randomized controlled trials have been performed.
   
   Despite methodologic limitations in previously reported studies, summaries of the literature support favorable and statistically significant positive outcomes in prosthesis use, general physical health, and walking ability. While some outcomes following osseointegration relate to changes that occur at the tissue level (residual limb bone changes at the implant interface), the most widely reported and significant outcomes relate to either functional performance or quality of life. Functional performance has been assessed through both self- report and physical performance measures. Less frequently reported outcomes include vibratory stimulation, biomechanics and energy consumption, pain, and economic implications.
   
   Complications associated with osseointegration implants used for the direct skeletal attachment of prosthetic limbs include infection (superficial and deep), other soft tissue complications, implant bending and breakage, implant loosening, peri-implant fracture, and implant failure. These complications may require additional complication-related procedures to be performed including long-term antibiotic use, soft tissue surgical debridement or revision, implant revision surgery, and implant removal.
   
   In the systematic review by Al Muderis et al. (2018), seven studies were identified reporting on complications associated with osseointegration. Studies reporting complications were rated as low quality and used different types of osseointegrated prostheses and protocols which resulted in inconsistent findings across the studies. The review by Hebert et al. (2017) identified that infection or other complications were reported in 13 of the 14 articles reviewed. This descriptive review noted that superficial infection was the most commonly reported complication across studies. Other complications such as fractures, implant loosening, implant breakage and need for surgical revision surgery were reported less frequently. The systematic review conducted by Kunutsor et al. (2018) identified 14 studies that specifically reported infection rates. The majority of infections were reported as low-grade soft tissue or superficial infections, which were treated effectively with oral antibiotics. Across these studies, the infection rate ranged from 1% (95% C.I. 0 to 5) to 77% (95% C.I. 59 to 88%) over a mean follow-up of five months to five years.
   
   The review conducted by Atallah et al. (2018), which included 12 studies, provided a more detailed review of both complications and complication- related interventions. Removal of the implant was the only complication that was reported in all articles included in the systematic review. This review is also unique in that subgroup analyses were performed by implant type (screw, press-fit, and other types of implants) and level of amputation (transfemoral, transtibial, and upper extremity amputation). Soft tissue infections and complications were commonly noted in the reviewed studies. Implant infection rates in transfemoral implants were (screw: 2±11%, press-fit: 0±3%, compress: 0%) and implant loosening rates were (screw: 6%, press-fit: 0±3%, compress: 0%).
   
   Matthews et al. (2019) reported osseointegration outcomes with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant in the United Kingdom between 1995 and 2018. Twenty eight percent of the implants failed and had to be removed during the mean follow-up period between 11.4 and 12.3 years with most failures related to deep infection. The study highlights that infection and implant failure can occur even 10 years or later after implant placement and that distal bone resorption is also common in the long-term.
   
   An article by Tillander et al. (2017) is a retrospective review of 96 individuals treated at the investigators center in Sweden between 1990 and 2010. Implant associated osteomyelitis was diagnosed in 16 subjects (10-year cumulative risk of 20%). Ten implants were removed for infection resulting in a 10-year cumulative risk of 9%.
   
   Brånemark et al. (2019) published a study of five-year outcomes and reported a revision-free survival rate of 45%. Complications included 34 patients with 70 superficial infection episodes including 14 deep infections. Fifteen patients had mechanical complications and four required implant removal.
   
   Hagberg et al. (2020) conducted a cohort study to assess a 15-year follow-up of transfemoral amputees with the OPRA bone-anchored transcutaneous prostheses, the survival rate of the osseointegrated implant part (the fixture) was 89% and 72% after seven and 15 years, respectively. However, a total of 61 patients (55%) had mechanical complications (mean 3.3 (SD 5.76)), resulting in exchange of the percutaneous implant parts and a positive relationship between a higher activity grade and the number of mechanical complications was noted. These findings emphasize that activity restrictions and improvements to the mechanical properties of the implant system are required. The study showed that the OPRA Implant System improved prosthetic use, led to better mobility, caused less problems, improved overall situation, and improved general physical health-related quality of life at 24 months compared to the subjects’ scores preoperatively. Early loosening was the most common complication requiring surgical removal of the OPRA Implant System. Eight percent (4/51) of patients had their implants removed due to loosening or persistent pain. The most frequently reported adverse events were superficial infections.
   
   Nebergall et al. (2012) conducted a study to address radiostereometric analysis (RSA) and periprosthetic bone remodeling to assess long-term fixation of the OPRA Implant System. The RSA analysis for the OPRA Implant System indicated stable fixation of the implant (no substantial motion) up to seven years after the second surgical procedure. Although some implants showed slight initial motion, the implants had stabilized at the five- year follow-up. The majority of radiographs showed only minimal amounts of bone remodeling around the implant, and ultimately this remodeling did not compromise implant fixation of performance. The team concluded that the OPRA Implant System provides a solution for patients who are unsuitable candidates for a conventional socket prosthesis.
   
   A recent retrospective cohort of 22 transfemoral amputees (Mortazavi, et al., 2025) confirmed that patients experienced improved functional outcomes and quality of life with the OPRA system after two years. While complication rates were notable, most were manageable with conservative treatment. Their findings suggest that osseointegrated prostheses offer an alternative to socket prostheses for suitable candidates, though further research with larger sample sizes is warranted to confirm long-term efficacy and safety.

3. U.S. Food & Drug Administration (FDA) Information
   VA generally only approves use of medical devices that have received at least Food & Drug Administration (FDA) clearance for 510(k) Premarket Notification. The following device has received Premarket Approval from the FDA and is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
   
   To search for devices that have received FDA 510(k) clearance or Premarket Approval (PMA), please visit the FDA Devices database.

4. Medicare Coverage Determinations
   There are currently no available Medicare coverage determinations for osseoanchored prostheses. VA and Medicare are governed by separate laws and regulations; thus, VA coverage determinations may be different.

5. TRICARE Policy Manual
   Available TRICARE coverage determinations are listed below as a resource. VA and TRICARE are governed by separate laws and regulations; thus, VA coverage determinations may be different.
   
   TRICARE Policy Manual 6010.63-M, Chapter 8, Section 5.1 

6. Health Care Procedural Coding Information
   The following CPT^®/HCPCS codes listed in this section are provided for informational purposes only. Inclusion or exclusion of a code does not constitute or imply VA coverage or provider reimbursement. The list of codes may not be all-inclusive since the American Medical Association (AMA) and Centers for Medicare & Medicaid Services (CMS) code updates may occur more frequently than CDI updates. Please refer to section II.a. in this document to review indications and clinical criteria for medical necessity.
   
   The following CPT codes are considered medically necessary/covered if the indications and clinical criteria outlined in section II.a. are met. Additional codes may also apply.

   CPT Code	Description
   27596	Amputation, thigh, through femur, any level; re- amputation
   C1734	Orthopedic/device/drug matrix for opposing bone-to- bone or soft tissue-to bone (Implantable)
   20902	Bone graft, any donor area; major or large

   CPT copyright ^© 2026 American Medical Association. All rights reserved.

IV. Definitions

Term	Definition
Abutment	A skin-penetrating device that is connected to the fixture part of the implant system for connection to the external prosthesis
Amputation	Removal of a limb by trauma, medical illness, or surgery
Metastasis	The spread of cancer cells from the place where they first formed to another part of the body. In metastasis, cancer cells break away from the original (primary) tumor, travel through the blood or lymph system, and form a new tumor in other organs or tissues of the body. The new, metastatic tumor is the same type of cancer as the primary tumor
Neuropathy	Sometimes referred to as peripheral neuropathy and associated with symptoms such as tingling, numbness, pain, or increased sensitivity to touch
Osseointegration	When bone ingrowth occurs into a metal implant. Osseointegration can be applied in persons with amputations as a method for anchoring an external prosthesis directly to the bone
Proprioception	A sensory function that allows one to determine the position of their body part
Prosthesis	An artificial device that replaces a missing body part, intended to restore the normal functions of the missing body part
Transfemoral amputation	An above knee amputation that is a surgical procedure performed to remove the lower limb at or above the knee joint
Ulceration	The formation of a break on the skin or on the surface of an organ

V. References

Al Muderis, M. M., Lu, W. Y., Li, J. J., Kaufman, K., Orendurff, M., Highsmith, M. J., Lunseth, P. A., & Kahle, J. T. (2018). Clinically Relevant Outcome Measures Following Limb Osseointegration; Systematic Review of the Literature. Journal of orthopaedic trauma, 32(2), e64–e75.

Atallah, R., Leijendekkers, R. A., Hoogeboom, T. J., & Frölke, J. P. (2018). Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review. PloS one, 13(8), e0201821.

Bigge, L. (2018, June 26). Bone-anchored prosthetics are life-changing innovations for Wounded Service members. National Museum of Health and Medicine. Retrieved on May 25, 2023

Brånemark, R. P., Hagberg, K., Kulbacka-Ortiz, K., Berlin, Ö., & Rydevik, B.
(2019). Osseointegrated Percutaneous Prosthetic System for the Treatment of Patients With Transfemoral Amputation: A Prospective Five-year Follow- up of Patient-reported Outcomes and Complications. The Journal of the American Academy of Orthopaedic Surgeons, 27(16), e743–e751.

Defense Health Agency (2021). Other Services – Medical Devices. TRICARE Policy Manual 6010.63-M. Chapter 8, Section 5.1. Retrieved Sept. 19, 2023

Gerzina, C., Potter, E., Haleem, A. M., & Dabash, S. (2020). The future of the amputees with osseointegration: A systematic review of literature. Journal of clinical orthopaedics and trauma, 11(Suppl 1), S142–S148.

GUIDE: Physical therapy guide to above-knee amputation (transfemoral amputation). Choose PT. (2018, November 15). Retrieved on May 26, 2023

Hagberg, K., Ghassemi Jahani, S. A., Kulbacka-Ortiz, K., Thomsen, P., Malchau, H., & Reinholdt, C. (2020). A 15-year follow-up of transfemoral amputees with bone- anchored transcutaneous prostheses. The bone & joint journal, 102-B(1), 55–63.

Hebert, J. S., Rehani, M., & Stiegelmar, R. (2017). Osseointegration for Lower-Limb Amputation: A Systematic Review of Clinical Outcomes. JBJS reviews, 5(10), e10.

Hoellwarth, J. S., Tetsworth, K., Rozbruch, S. R., Handal, M. B., Coughlan, A., & Al Muderis, M. (2020). Osseointegration for Amputees: Current Implants, Techniques, and Future Directions. JBJS reviews, 8(3), e0043.

Hospital for Special Surgery. (n.d.). Osseointegration limb replacement: More control for amputees. Hospital for Special Surgery. Retrieved on May 29, 2023

Hoyt, B. W., Walsh, S. A., & Forsberg, J. A. (2020). Osseointegrated prostheses for the rehabilitation of amputees (OPRA): results and clinical perspective. Expert review of medical devices, 17(1), 17–25.

INTEGRUM. (2021). OPRATM Implant System. Integrum. Retrieved on May 25, 2023.

Integrum AB. (n.d.). Food and Drug Administration. OPRA Implant System Instructions for Use. Retrieved on May 25, 2023.

Kunutsor, S. K., Gillatt, D., & Blom, A. W. (2018). Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation. The British journal of surgery, 105(13), 1731–1741.

Leijendekkers, R. A., van Hinte, G., Frölke, J. P., van de Meent, H., Nijhuis-van der Sanden, M. W., & Staal, J. B. (2017). Comparison of bone-anchored prostheses and socket prostheses for patients with a lower extremity amputation: a systematic review. Disability and rehabilitation, 39(11), 1045–1058.

Leijendekkers, R. A., van Hinte, G., Frölke, J. P., van de Meent, H., Atsma, F., Nijhuis-van der Sanden, M. W., & Hoogeboom, T. J. (2019). Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study. Clinical rehabilitation, 33(3), 450–464.

Li, Y., & Brånemark, R. (2017). Osseointegrated prostheses for rehabilitation following amputation: The pioneering Swedish model. Osseointegrierte Prothesen zur Rehabilitation nach Amputation: Das wegweisende schwedische Modell. Der Unfallchirurg, 120(4), 285–292.

Lundberg, M., Hagberg, K., & Bullington, J. (2011). My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb. Prosthetics and orthotics international, 35(2), 207–214.

Matthews, D. J., Arastu, M., Uden, M., Sullivan, J. P., Bolsakova, K., Robinson, K., Sooriakumaran, S., & Ward, D. (2019). UK trial of the Osseointegrated Prosthesis for the Rehabilitation for Amputees: 1995-2018. Prosthetics and orthotics international, 43(1), 112–122.

Military Health System Amputation Care Community of Interest. (2021) Osseointegration Fact Sheet. Retrieved Sept. 08, 2023.

Mortazavi, S. M. J., Abbaspour, A., Seyedtabaei, S. M. M., Saberi, S., & Khabiri, S.S. (2025). Improving quality of life for transfemoral amputees: results from a two- year study of the OPRA implant system and rehabilitation protocol. European journal of orthopaedic surgery & traumatology : orthopedie traumatologie, 35(1).

National Cancer Institute at the National Institutes of Health. (n.d.). NCI Dictionary of Cancer terms. National Cancer Institute. Retrieved on May 30, 2023.

NCI Dictionary of Cancer terms. National Cancer Institute. (n.d.-b). Retrieved on May 30, 2023.

Nebergall, A., Bragdon, C., Antonellis, A., Kärrholm, J., Brånemark, R., & Malchau, H. (2012). Stable fixation of an osseointegated implant system for above-the- knee amputees: titel RSA and radiographic evaluation of migration and bone remodeling in 55 cases. Acta orthopaedica, 83(2), 121–128.

NYU Langone. (2022). NYU Langone’s Center for Amputation Reconstruction Launches Osseointegration program with FDA-approved Implant System. NYU Langone News. Retrieved on May 29, 2023.

OPRA Patient information sheet – Veterans Affairs. OPRATM Implant System Description and General Considerations. (n.d.). Retrieved on May 29, 2023.

Orthopedics (SOM). University of Colorado School of Medicine. (n.d.). Retrieved on May 30, 2023.

Patient Labeling OPRA Implant System. (2021). Retrieved on May 25, 2023.

Reetz, D., Atallah, R., Mohamed, J., van de Meent, H., Frölke, J. P. M., & Leijendekkers, R. (2020). Safety and Performance of Bone-Anchored Prostheses in Persons with a Transfemoral Amputation: A 5-Year Follow-up Study. The Journal of bone and joint surgery. American volume, 102(15), 1329–1335.

Salomon, S. H., Kelser, E. A., Salomon, S. H., & By. (2023). What is neuropathy? symptoms, causes, diagnosis, treatment, and prevention. EverydayHealth.com. Retrieved May 26, 2023.

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA). (2020). Food and Drug Administration. Retrieved May 26, 2023.

Tillander, J., Hagberg, K., Berlin, Ö., Hagberg, L., & Brånemark, R. (2017). Osteomyelitis Risk in Patients With Transfemoral Amputations Treated With Osseointegration Prostheses. Clinical orthopaedics and related research, 475(12), 3100–3108.

UCSF. (2023). Osseointegration Surgery at UCSF is First of Its Kind in U.S. | UC San Francisco. Retrieved May 29, 2023.

US Department of Veterans Affairs Rehabilitation and Prosthetic Services. (n.d.). Osseoanchored Prostheses for The Rehabilitation of Amputees (OPRATM) Implant System Clinical Guidance.

US Department of Veterans Affairs. (n.d.). OPRATM Patient Information Sheet.

U.S. Food & Drug Administration Premarket Approval (PMA) Database. (n.d.). Retrieved May 25, 2023.

van Eck CF, McGough RL. (2015) Clinical outcome of osseointegrated prostheses for lower extremity amputations: A systematic review of the literature. Current Orthopaedic Practice. 26(4):349-57

Whiteman, T. (2023). Osseointegration Clinic: Johns Hopkins Department of Orthopaedic Surgery. Osseointegration Clinic | Johns Hopkins Department of. Retrieved May 25, 2023.

Zaid, M. B., OʼDonnell, R. J., Potter, B. K., & Forsberg, J. A. (2019). Orthopaedic Osseointegration: State of the Art. The Journal of the American Academy of Orthopaedic Surgeons, 27(22), e977–e985.

VI. CDI History/Revision Information

Date	Summary of Updates
06/01/2025	Added evidence summary from Mortazavi, et al., 2025 Updated Definitions section
04/30/2024	New CDI created describing medically necessary indications

---