The Osseointegration Group of Australia Accelerated Protocol (OGAAP-1) for two-stage osseointegrated reconstruction of amputated limbs

Muderis, Munjed Al; Tetsworth, Kevin; Khemka, Aditya; Wilmot, Samuel G.; Bosley, Belinda; Lord, Sarah J.; Glatt, Vaida

doi:10.1302/0301-620x.98b7.37547

Cited by 81 publications

(124 citation statements)

References 35 publications

Supporting

Mentioning

109

Contrasting

Unclassified

Order By: Relevance

“…The patients in the latter studies overlapped with those in another study already included in the review. The remaining 22 articles comprising 13 unique studies met the inclusion criteria and were included in the review.…”

Section: Resultsmentioning

confidence: 99%

Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation

Kunutsor

Gillatt

Blom

2018

British Journal of Surgery

View full text Add to dashboard Cite

Background Osseointegration, an approach for direct skeletal attachment of a prosthesis to an amputated limb, may address many of the problems associated with socket prostheses. The safety of osseointegration remains uncertain. The aim of this study was to summarize evidence on functional and clinical outcomes, as well as adverse effects of osseointegration for patients with a limb amputation. Methods MEDLINE, Embase, Web of Science and the Cochrane Library were searched to April 2018. Eligible studies were observational, case and qualitative studies, and RCTs conducted in patients with a limb amputation, who were managed with osseointegrated prostheses and had follow‐up data. Results Twenty‐two eligible articles comprising 13 unique studies were included. No RCT was identified. Apart from three case reports that comprised one to five patients, the sample size of studies ranged from 11 to 100 participants. All relevant studies reported improvement in functional outcomes (walking ability, prosthetic use and mobility), satisfaction and quality of life following osseointegration, compared with their preoperative status or when using a conventional socket prosthesis. Infection rates ranged from 1 (95 per cent c.i. 0 to 5) to 77 (59 to 88) per cent. The majority of infections were described as low‐grade soft tissue or superficial infections related to the skin–implant interface, and were treated effectively with antibiotics. None of the studies reported additional amputation or death as a result of osseointegration. Conclusion Osseointegration after limb amputation improves prosthetic use, comfort when sitting, walking ability, mobility, gait and quality of life. However, it is associated with an increased risk of soft tissue infection.

show abstract

Section: Resultsmentioning

confidence: 99%

Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation

Kunutsor

Gillatt

Blom

2018

British Journal of Surgery

View full text Add to dashboard Cite

show abstract

“…17 27 Recently, a comprehensive surgical and rehabilitation protocol (OGAAP-1) has been developed for procedures involving osseointegrated implants which are currently used in Australia and the Netherlands, with press-fit designs that encourage bone ingrowth. 28 This protocol emphasises an integrated approach for the management of patients with lower limb amputations, and revolves around two-stage osseointegration surgery with a 4-6-week interval between stages. Preliminary results have demonstrated significant improvements in quality of life and functional outcome measures, 28 while maintaining very reasonable complication rates.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…From the time of the initial surgery, these procedures require up to 12-18 months for the completion of reconstruction and rehabilitation with screw-fixation implants, and at least 4-5 months even under the accelerated OGAAP-1 protocol. 28 Since April 2014, however, a single-stage osseointegration procedure has been routinely performed by the Osseointegration Group of Australia (OGA) under the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2). This protocol reduces the overall time required for the definitive osseointegrated reconstruction and rehabilitation of lower limb amputees to ∼3-6 weeks, which is substantially shorter compared with any currently available two-stage procedure.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…The minimum follow-up period of 2 years is chosen as our previous experience indicates that peak gains in function and quality of life as a result of osseointegrated reconstruction of amputated limbs are obtained within 12 months postoperation, 28 and changes in related outcomes can be expected to plateau thereafter. Our previous experience also shows that 2 years of follow-up will provide sufficient time for the monitoring of any major adverse events (such as infection) following surgery.…”

Section: Study Outcomes and Follow-up Study Outcomesmentioning

confidence: 99%

See 1 more Smart Citation

Single-stage osseointegrated reconstruction and rehabilitation of lower limb amputees: the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a prospective cohort study

Muderis

Tetsworth

et al. 2017

BMJ Open

View full text Add to dashboard Cite

IntroductionLower limb amputations have detrimental influences on the quality of life, function and body image of the affected patients. Following amputation, prolonged rehabilitation is required for patients to be fitted with traditional socket prostheses, and many patients experience symptomatic socket–residuum interface problems which lead to reduced prosthetic use and quality of life. Osseointegration has recently emerged as a novel approach for the reconstruction of amputated limbs, which overcomes many of the socket-related problems by directly attaching the prosthesis to the skeletal residuum. To date, the vast majority of osseointegration procedures worldwide have been performed in 2 stages, which require at least 4 months and up to 18 months for the completion of reconstruction and rehabilitation from the time of the initial surgery. The current prospective cohort study evaluates the safety and efficacy of a single-stage osseointegration procedure performed under the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2), which dramatically reduces the time of recovery to ∼3–6 weeks.Methods and analysisThe inclusion criteria for osseointegrated reconstruction under the OGAAP-2 procedure are age over 18 years, unilateral transfemoral amputation and experiencing problems or difficulties in using socket prostheses. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values are compared for each outcome measure, and the benefits and harms of the single-stage OGAAP-2 procedure will be compared with the results obtained using a previously employed 2-stage procedure.Ethics and disseminationThis study has received ethics approval from the University of Notre Dame, Sydney, Australia (014153S). The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences.

show abstract

“…BAPs are used in patients with a transfemoral [23–30] or transtibial amputation [31–33]. To date, there are two types of implants available: a screw BAP [34, 35] and a press-fit BAP [29, 36].…”

Section: Introductionmentioning

confidence: 99%

Long-term outcomes following lower extremity press-fit bone-anchored prosthesis surgery: a 5-year longitudinal study protocol

Leijendekkers

Staal

Hinte

et al. 2016

BMC Musculoskelet Disord

View full text Add to dashboard Cite

BackgroundPatients with lower extremity amputation frequently suffer from socket-related problems. This seriously limits prosthesis use, level of activity and health-related quality of life (HRQoL). An additional problem in patients with lower extremity amputation are asymmetries in gait kinematics possibly accounting for back pain. Bone-anchored prostheses (BAPs) are a possible solution for socket-related problems. Knowledge concerning the level of function, activity and HRQoL after surgery is limited.The aims of this ongoing study are to: a) describe changes in the level of function, activity, HRQoL and satisfaction over time compared to baseline before surgery; b) examine potential predictors for changes in kinematics, prosthetic use, walking ability, HRQoL, prosthesis comfort over time and level of stump pain at follow-up; c) examine potential mechanisms for change of back pain over time by identifying determinants, moderators and mediators.Methods/designA prospective 5-year longitudinal study with multiple follow-ups. All adults, between May 2014 and May 2018, with lower extremity amputation receiving a press-fit BAP are enrolled consecutively. Patients with socket-related problems and trauma, tumour resection or stable vascular disease as cause of primary amputation will be included. Exclusion criteria are severe cognitive or psychiatric disorders. Follow-ups are planned at six-months, one-, two- and five-years after BAP surgery. The main study outcomes follow, in part, the ICF classification: a) level of function defined as kinematics in coronal plane, hip abductor strength, prosthetic use, back pain and stump pain; b) level of activity defined as mobility level and walking ability; c) HRQoL; d) satisfaction defined as prosthesis comfort and global perceived effect. Changes over time for the continuous outcomes and the dichotomized outcome (back pain) will be analysed using generalised estimating equations (GEE). Multivariate GEE will be used to identify potential predictors for change of coronal plane kinematics, prosthetic use, walking ability, HRQoL, prosthesis comfort and for the level of post-operative stump pain. Finally, potential mechanisms for change in back pain frequency will be explored using coronal plane kinematics as a potential determinant, stump pain as moderator and hip abductor strength as mediator.DiscussionThis study may identify predictors for clinically relevant outcome measures.Trial registration NTR5776. Registered 11 March 2016, retrospectively registered.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1341-z) contains supplementary material, which is available to authorized users.

show abstract

The Osseointegration Group of Australia Accelerated Protocol (OGAAP-1) for two-stage osseointegrated reconstruction of amputated limbs

Cited by 81 publications

References 35 publications

Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation

Systematic review of the safety and efficacy of osseointegration prosthesis after limb amputation

Single-stage osseointegrated reconstruction and rehabilitation of lower limb amputees: the Osseointegration Group of Australia Accelerated Protocol-2 (OGAAP-2) for a prospective cohort study

Long-term outcomes following lower extremity press-fit bone-anchored prosthesis surgery: a 5-year longitudinal study protocol

Contact Info

Product

Resources

About