Osseointegration - Clinical Evidence & Research

Clinical Evidence - Osseointegration Surgery for Amputees

Socket-based prostheses have been the standard treatment for amputees for centuries, dating back to the 1500s1. In the 1940s1, osseointegration surgery emerged as a groundbreaking alternative in the field of orthopaedics, with the first human procedure being conducted later in the 90s2.

However, due to its novelty, limited availability, and the heterogeneity of amputations, implants, and techniques, there is still a limited number of scientific and clinical reviews with a large cohort of orthopaedic patients. Despite these challenges, several scientific articles have published clinical evidence of osseointegration outcomes and compared it to socket-based prostheses1.

Below you find supporting information about the benefits and the complications that can occur with the procedure.

Benefits of Osseointegration

Osseointegration surgery compared with socket-based prosthesis has shown several benefits3:

1. Osseointegration may prevent soft tissue problems associated with socket-based prostheses​

In 2004, a study surveyed 935 patients to evaluate their satisfaction with socket prostheses. The study found that one-third of the participants were dissatisfied with the comfort of their prosthesis5.

Another study conducted by the University of Maryland interviewed 78 amputees using socket-based prostheses. The research revealed that 95% of the users wore their prosthesis for more than 80 hours per week, but 25% of them reported experiencing skin problems, ulcers, and pain. The study concluded that only 43% of the users were satisfied with the comfort of their prosthesis4.

A survey conducted among 210 amputees who used socket-based prostheses and published in a dermatology journal found that 34% of the participants had dermatological problems, with contact dermatitis being the most common issue6.

2. Osseointegration surgery can improve hip range of motion in amputees​

Hagberg, K. et al. analyzed the hip range of motion in above knee amputees: 43 socket prosthesis users and 20 osseointegration patients.

The results demonstrated that all socket users had a reduced hip range of motion, and 19 of them experienced discomfort when sitting. In contrast, none of the osseointegration patients reported any reduction in hip range of motion, and only one patient reported discomfort when sitting7.

3. Osseointegration can improve walking speed and ability ​

Hendrik Van de Meent, MD, PhD treated 22 patients who were experiencing skin problems and discomfort, preventing them from using their socket prosthesis. The patients underwent an osseointegration procedure, and their mobility and quality of life were evaluated through different types of tests10.

a. The Global score of the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA), test designed to evaluate the overall health and mobility of non-elderly transfemoral amputees, with scores ranging from 0 to 100, with zero being the worst outcome.
The socket group had a mean score of 39 ± 4.7 points, while the osseointegration group scored 63 ± 5.3 points10.

b. A Timed Up & Go (TUG) test to measure the time taken by the individuals to walk a distance of 3 meters to a chair and back. The socket group took a longer time to complete the distance, with a mean time of 15.1 ± 2.1 seconds, while the osseointegration group took significantly less time at 8.1 ± 0.7 seconds10.

c. A 6-minute walk test (6MWT) to assess the distance covered over 6 minutes as a measure of aerobic capacity. The socket group scored 321 ± 28m while the osseointegration group scored 423 ± 21. During the oxygen consumption test, the individuals with a socket consumed significantly more oxygen (1330 ± 310mL/min) than the osseointegration patients (1093±361mL/min)10.

d. Prosthesis use measured in hours per week: According to the data, osseointegration patients wore their prosthesis for a longer time per week (101 ± 2.4 hours) compared to those with a socket prosthesis, who wore it for a shorter duration (56 ± 7.9 hours)10.

4. Osseointegration patients have improved physiological weight bearing on amputated limb​

Correct alignment, balanced force distribution, and posture are key elements to avoid the development of musculoskeletal pathology. Excessive load on the intact limb can lead to early osteoarthritis in the healthy knee and hip14.

 Stability in the socket depends grossly on the quality of soft tissues. Even a well-fitting socket may cause too much compression and problems related to it. Socket prostheses also allow for movement of the femoral bone within the soft tissues, as seen in the image with a patient on the left side using a socket.

Since the osseointegration procedure allows  the prosthetic components to be anchored directly to the bony residuum, the prosthetic fitting does not rely on the soft tissue mantle. The stability of the prosthesis is improved, resulting in better limb control and a more natural load on the limb.  With osseointegration, the remnant of the femur is aligned with the axis of the limb, as seen in the patient on the right side of the image15.

Osteopenia and osteoporosis are conditions characterised by low bone density. Disuse osteopenia usually develops in amputees around the hip joint and lumbar spine, due to insufficient load through the residual bone. This can lead to hip or lower back pain which is frequently reported by socket users. The pain may also stem from alterations in the body’s biomechanics or discrepancies in leg length14.

A 2019 study examined the bone mineral density of 48 unilateral amputees who underwent osseointegration. The researchers found that one and two years after the procedure, the implants effectively triggered a response in the lumbar spine that reduced bone loss. This effect was also observed in the femoral neck15.

The graph demonstrates an increase in bone mineral density among the patient groups over time. The solid blue columns represent the baseline, while the checked columns indicate density one year after the procedure. The striped column illustrates the density two years after the osseointegration procedure was performed.15

Bone Mineral Density

5. Osseointegration surgery may improve bone perception and sensory feedback​

Several studies simulated walking-induced vibrations to assess their correlation with a sense of safety while walking. All studies demonstrated greater perception of ground reaction force in patients with osseointegration as compared to those with a socket-based prosthesis. However, due to the limited number of patients evaluated and lack of standardisation in the techniques applied, definitive conclusions could not be established18,20.

6. Osseointegration can help improving patient's satisfaction and quality of life ​

Quality of life refers to evaluating a person’s overall well-being, encompassing not just their physical health, but also their psychological and social states. In the field of medicine, this assessment is often carried out using questionnaires that yield quantitative data, allowing for comparisons between individuals undergoing different treatments.

A study analysing the quality of life of 18 patients who underwent osseointegration was published in the Prosthetics and Orthotics International Journal. The researchers employed two questionnaires to evaluate the preoperative condition of the patients. Two additional questionnaires were then administered to the same patients two years after receiving osseointegration. The results demonstrated a substantial enhancement in the patients’ prosthetic use, mobility, and overall quality of life19.

Professor Munjed Al Muderis, one of the pioneers in osseointegration, conducted a study on 50 patients who underwent unilateral osseointegration. The study assessed patients’ quality of life through different questionnaires and a 6MWT to assess walking ability and speed. In addition, a Timed Up and Go (TUG) test was conducted one year after the procedure. Despite 27 out of the 50 patients experiencing variety of adverse events, the study reported significant improvements in patients’ quality of life, walking ability, and speed21.

Complications associated with Osseointegration

While osseointegration is a non-standard procedure offered to amputees, studies indicate that it is as good as, if not better than socket-based prostheses. However, like any medical treatment, there are risks that need to be considered before undergoing the procedure. Here are some of the common risks to be aware of when considering osseointegration surgery:

1. Infection

One of the most common risks associated with osseointegration surgery is the risk of infection. Since the surgery involves inserting a titanium implant into the bone through an opening of the skin, this will lead to a higher risk of infection and can occur at any time after implantation. While most infections can be effectively managed29 an infection may result in implant failure if left neglected.

2. Implant Loosening

Another risk of osseointegration surgery is the failure of the implant to attach properly to the bone. This can occur if the bone is not strong enough to support the implant or if the implant is not inserted correctly. Loosening can also occur if too much load is placed on the implant. In some cases, the implant may need to be removed and reinserted.

3. Complications with anesthesia

The administration of anesthesia during surgical procedures presents its own risks, such as respiratory complications and allergic reactions.

4. Nerve or blood vessel damage

The surgical process includes placing a metal implant into the bone while carefully managing the surrounding soft tissues. However, this procedure carries the risk of harm to nearby nerves and blood vessels, which may result in discomfort, numbness, or decreased sensation in the affected area.

5. Bone Fracture

When an implant is surgically inserted into the bone, the force applied during the procedure can place stress on the bone, creating the risk of a fracture. Traumatic incidents such as impacts or falls following the surgery may also lead to peri-prosthetic fractures. The management of these fractures is well-documented and familiar30, and can be obtained from numerous orthopaedic trauma centres.

6. Inadequate healing and skin irritation

There are several factors that can contribute to inadequate healing of the surgical site, including malnutrition or reduced blood circulation in the area. Once the surgical wound has healed, the pressure and friction generated by the prosthetic components against the skin and soft tissues can result in irritation and sore skin.

7. Maggot infections

Myiasis is an infection caused by fly larvae, typically found in tropical and subtropical regions. The exposed nature of the stoma increases the risk of flies depositing their eggs, which can lead to the hatching larvae burrowing into the stoma or surrounding skin. Maintaining proper hygiene of the stoma is crucial to prevent and treat maggot infestations effectively.

8. Pain

Pain is a common risk associated with amputation surgery. It can manifest during the healing phase or endure for an extended period. Different types of pain may occur, including phantom limb pain, characterised by sensations of pain in the absent limb. Stump pain, on the other hand, refers to pain experienced in the remaining portion of the amputated limb, often associated with neuromas. Amputees frequently suffer from muscle and joint pain due to changes in their gait and heightened pressure on other body areas.

This page aims to provide readers with an overview of the clinical and scientific evidence on osseointegration. The original research papers used to create this summary are listed below for your review. We hope you find this information helpful.


1. Hoellwarth, J.S. et al. (2022) “The clinical history and basic science origins of transcutaneous osseointegration for amputees,” Advances in Orthopedics, 2022, pp. 1–14. Available at: https://doi.org/10.1155/2022/7960559. 

2. Li, Y. and Felländer-Tsai, L. (2021) “The bone anchored prostheses for amputees – historical development, current status, and future aspects,” Biomaterials, 273, p. 120836. Available at: https://doi.org/10.1016/j.biomaterials.2021.120836

3. Al Muderis, M.M. et al. (2018) “Clinically relevant outcome measures following limb osseointegration; systematic review of the literature,” Journal of Orthopaedic Trauma, 32(2). Available at: https://doi.org/10.1097/bot.0000000000001031

4. Dillingham, T.R. et al. (2001) “Use and satisfaction with prosthetic devices among persons with trauma-related amputations,” American Journal of Physical Medicine & Rehabilitation, 80(8), pp. 563–571. Available at: https://doi.org/10.1097/00002060-200108000-00003.   

5. Pezzin, L.E. et al. (2004) “Use and Satisfaction With Prosthetic Limb Devices and Related Services,” Arch Phys Med Rehabil, 85, pp. 723–729.   

6. Lyon, C.C. et al. (2000) “Skin disorders in amputees,” Journal of the American Academy of Dermatology, 42(3), pp. 501–507. Available at: https://doi.org/10.1016/s0190-9622(00)90227-5.  

 7. Hagberg, K. et al. (2005) “Socket versus bone-anchored trans-femoral prostheses,” Prosthetics & Orthotics International, 29(2), pp. 153–163. Available at: https://doi.org/10.1080/03093640500238014

8. Tranberg, R., Zügner, R. and Kärrholm, J. (2011) “Improvements in hip- and pelvic motion for patients with osseointegrated trans-femoral prostheses,” Gait & Posture, 33(2), pp. 165–168. Available at: https://doi.org/10.1016/j.gaitpost.2010.11.004.  

9. Kahle, J.T. and Muderis, M.A. (2016) “What science says about the clinical outcome of osseointegration,” Technology Review, December, pp. 38–41. 

10. Van de Meent, H., Hopman, M.T. and Frölke, J.P. (2013) “Walking ability and quality of life in subjects with transfemoral amputation: A comparison of osseointegration with socket prostheses,” Archives of Physical Medicine and Rehabilitation, 94(11), pp. 2174–2178. Available at: https://doi.org/10.1016/j.apmr.2013.05.020.  

11. Hagberg, K., Branemark, R. and Hagg, O. (2004) “Questionnaire for persons with a transfemoral amputation (Q-TFA): Initial validity and reliability of a new outcome measure,” The Journal of Rehabilitation Research and Development, 41(5), p. 695. Available at: https://doi.org/10.1682/jrrd.2003.11.0167.  

12. Assessment timed up & go (TUG) – centers for disease control and prevention (2017) Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/steadi/pdf/TUG_Test-print.pdf (Accessed: October 27, 2022).  

13. Fell, B., Hanekom, S. and Heine, M. (2022) “A modified six-minute walk test (6MWT) for low-resource settings-a cross-sectional study,” Heart & Lung, 52, pp. 117–122. Available at: https://doi.org/10.1016/j.hrtlng.2021.12.008

14. Gailey, R. (2008) “Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use,” The Journal of Rehabilitation Research and Development, 45(1), pp. 15–30. Available at: https://doi.org/10.1682/jrrd.2006.11.0147.  

15. Thomson, S. et al. (2019) “Proximal bone remodeling in lower limb amputees reconstructed with an osseointegrated prosthesis,” Journal of Orthopaedic Research, 37(12), pp. 2524–2530. Available at: https://doi.org/10.1002/jor.24445

17. Lee, W.C.C. et al. (2004) “Finite element modeling of the contact interface between trans-tibial residual limb and prosthetic socket,” Medical Engineering & Physics, 26(8), pp. 655–662. Available at: https://doi.org/10.1016/j.medengphy.2004.04.010

18. Hagberg K, Haggstrom E, Jonsson S, Rydevik Hagberg, K. et al. (no date) “Osseoperception and osseointegrated prosthetic limbs,” Psychoprosthetics, pp. 131–140. Available at: https://doi.org/10.1007/978-1-84628-980-4_10.  

19. Jacobs, R. et al. (2000) “Evaluation of the psychophysical detection threshold level for vibrotactile and pressure stimulation of prosthetic limbs using bone anchorage or soft tissue support,” Prosthetics & Orthotics International, 24(2), pp. 133–142. Available at: https://doi.org/10.1080/03093640008726536.  

20. Hagberg, K. et al. (2008) “Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up,” Prosthetics & Orthotics International, 32(1), pp. 29–41. Available at: https://doi.org/10.1080/03093640701553922.  

21. Häggström, E. et al. (2013) “Vibrotactile evaluation: Osseointegrated versus socket-suspended transfemoral prostheses,” Journal of Rehabilitation Research and Development, 50(10), pp. 1423–1434. Available at: https://doi.org/10.1682/jrrd.2012.08.0135.  

22. Muderis, M.A. et al. (2016) “The Osseointegration Group of Australia accelerated protocol (OGAAP-1) for two-stage osseointegrated reconstruction of amputated limbs,” The Bone & Joint Journal, 98-B(7), pp. 952–960. Available at: https://doi.org/10.1302/0301-620x.98b7.37547

23. Aschoff, H.H. et al. (2010) “Transcutaneous, distal femoral, intramedullary attachment for above-the-knee prostheses: An Endo-Exo Device,” Journal of Bone and Joint Surgery, 92(Supplement_2), pp. 180–186. Available at: https://doi.org/10.2106/jbjs.j.00806.  

24. Sullivan, J. et al. (2003) “Rehabilitation of the transfemoral amputee with an osseointegrated prosthesis,” Prosthetics & Orthotics International, 27(2), pp. 114–120. Available at: https://doi.org/10.1080/03093640308726667

25. Nebergall, A. et al. (2012) “Stable fixation of an osseointegated implant system for above-the-knee amputees,” Acta Orthopaedica, 83(2), pp. 121–128. Available at: https://doi.org/10.3109/17453674.2012.678799.  

26. Tillander, J. et al. (2010) “Osseointegrated titanium implants for limb prostheses attachments: Infectious complications,” Clinical Orthopaedics & Related Research, 468(10), pp. 2781–2788. Available at: https://doi.org/10.1007/s11999-010-1370-0.   

27. Muderis, M.A. et al. (2016) “Direct skeletal attachment prosthesis for the amputee athlete: The unknown potential,” Sports Engineering, 19(3), pp. 141–145. Available at: https://doi.org/10.1007/s12283-016-0196-8.  

28. Brånemark, R. et al. (2014) “A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation,” The Bone & Joint Journal, 96-B(1), pp. 106–113. Available at: https://doi.org/10.1302/0301-620x.96b1.31905.  

29. Al Muderis, Munjed MB ChB, FRACS, FAOrthA1,2,3,4,a; Khemka, Aditya MBBS, MS Ortho, PhDc1,2,b; Lord, Sarah J. MBBS, MSc1,5,c; Van de Meent, Henk MD, PhD6,d; Frölke, Jan Paul M. MD, PhD6,e. Safety of Osseointegrated Implants for Transfemoral Amputees: A Two-Center Prospective Cohort Study. The Journal of Bone and Joint Surgery 98(11):p 900-909, June 1, 2016. Available at: https://doi.org/10.2106/JBJS.15.00808 

30. Hoellwarth JS, Tetsworth K, Kendrew J, et al. Periprosthetic osseointegration fractures are infrequent and management is familiar. Bone Joint J. 2020;102-B(2):162-169. Available at: https://doi.org/10.1302/0301-620X.102B2.BJJ-2019-0697.R2 

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