Opra implant system
The Integrum OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System is an innovative method that significantly improves the quality of life for individuals with amputations. The system has been used by hundreds of amputees since the world's first surgery in 1990 and has been proven in several clinical studies. The OPRA Implant System is unique and available for both upper and lower limbs.
Bone anchored prostheses
The OPRA Implant System is a bone anchored system based on osseointegration where the prostheses are directly attached to the bone and thus avoiding the use of socket. The system utilizes a modular design consisting of three main parts that have been developed and refined over the years based on many years of development and clinical research. The unique design ensures protection of the patient by avoiding bone fractures from accidental loads.
- Fixture: Anchoring element inserted into the patient’s bone
- Abutment: Skin penetrating connection attached to the fixture
- Abutment Screw: A screw made of titanium alloy that locks the Abutment to the Fixture
A well proven system used in over 400 surgeries
The components are coated with a new surface technology, BioHelix™, that has been developed by Integrum after 10 years of research and clinical testing. The new surface will take osseointegration to the next level and promote faster, stronger attachment to the bone, thereby increasing the strength of the bone-to-implant interface. The prosthesis is connected to the OPRA Implant System using a connection and load controlling device. Integrum has developed specific components each customized for different indications levels, including both upper and lower limb.
The OPRA components are implanted during two surgeries (read more about the Surgical procedure). The first surgery with the OPRA Implant System was performed in 1990 by Dr. Rickard Brånemark and since the start over 25 years ago, over 400 surgeries have been performed in twelve countries. Clinical studies show that the surgery significantly improves the quality of life for amputees*.
*See e.g.: Brånemark, R., Berlin, Ö., Hagberg, K., Bergh, P., Gunterberg, B., & Rydevik, B. (2014). A novel osseointegrated, percutaneous prosthetic system for treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 96-B(1), 106–113. or refer to Scientific Data & Resources for full list of references
Unique system for both upper and lower limbs
The OPRA method provides direct bone anchorage by surgically implanting a titanium screw into the bone. The system is applicable for both upper and lower limbs for the following amputation levels:
- Transhumeral (above-elbow) amputations
- Transradial (below-elbow) amputations
- Finger / thumb amputations
- Transfemoral (above-knee) amputations
- Transtibial (below-knee) amputations
Proven in clinical studies
A clinical investigation of 51 subjects with transfemoral amputation (above knee) treated with OPRA reported functionality with a cumulative survival rate of 92% at 2 years follow-up (Brånemark et al, 2014).1 The study showed statistically significantly increased prosthetic use, better prosthetic mobility, fewer problems, a better overall amputation situation and improved quality
of life. Results from in-depth interviews reported by Lundberg et al (2011)2 showed that patients using a bone-anchored prosthesis experienced a revolutionary change that went beyond the functional gains, to improve quality of life. One of the patients expressed this in the following way:
“The other prosthesis ruled my life, it was my master in a way, it’s inevitable…it affected my mood and my interest in doing things that I knew would demand an extra effort. You had to weigh the pros and cons and that’s all gone now. Now it’s actually me…I am in command and not the left leg (socket prosthesis) and that’s a big difference.”
1Brånemark, R., Berlin, Ö., Hagberg, K., Bergh, P., Gunterberg, B., & Rydevik, B. (2014). A novel osseointegrated, percutaneous prosthetic system for treatment of patients with transfemoral amputation: A prospective study of 51 patients. Bone Joint J, 96-B(1), 106–113
2Lundberg, M., Hagberg, K., & Bullington, J. (2011). My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb. Prosthet Orthot Int, 35(2), 207–14
- Increased range of motion
- Eliminates pressure, sores and pain caused by the socket
- Stable attachment
- Easy attachment and detachment
- Better walking ability
- Improved osseoperception (sensory feedback)
- Can be worn all day, every day
- Improved sitting comfort
- No socket adjustments required
- Suitable for short amputation stumps
Our current opra implant system products
Several improvements have been finalized in 2015. We are proud to announce that we have been able to develop an enhanced system. An upgraded abutment screw and abutment will be introduced 2016. The mechanical properties such as fatigue and wear will be improved.
OPRA Fixture BioHelix™
A new surface technology has been introduced (BioHelix™), after 10 years of research and clinical testing. The new surface will take osseointegration to the next level and promote faster, stronger attachment to bone, thereby increasing the strength of the bone-toimplant interface.
It started already in 2006 when Integrum´s unique BioHelix™ surface was developed in close collaboration with the Department of Biomaterials at the University of Gothenburg. Since then, several experimental studies have shown more rapid healing and stronger osseointegration.
Features of the OPRA Fixture BioHelix™:
- Decreased time to healing and improved bone-to-implant stabilty
- Increased degree of osseointegration, created by its micro- and nano-sized structures that takes osseointegration to the next level
- Significantly increased strength of the bone-to-implant interface (proven in several studies)
“The other prosthesis ruled my life, it was my master in a way, it’s inevitable…it affected my mood and my interest in doing things that I knew would demand an extra effort. You had to weigh the pros and cons and that’s all gone now. Now it’s actually me…I am in command and not the left leg (socket prosthesis) and that’s a big difference.”Read more