Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up

doi:10.1016/j.apmr.2014.07.009

Archives of Physical Medicine and Rehabilitation

Volume 95, Issue 11, November 2014, Pages 2120-2127

https://doi.org/10.1016/j.apmr.2014.07.009 Get rights and content

Abstract

Objective

To report outcomes regarding general and specific physical health-related quality of life of treatment with percutaneous osseointegrated prostheses.

Design

Prospective 2-year case-control study.

Setting

University hospital.

Participants

Individuals (N=39; mean age, 44±12.4y) with unilateral transfemoral amputation as a result of trauma (n=23), tumor (n=11), or other cause (n=5). At baseline, 33 of the 39 participants used socket-suspended prostheses.

Intervention

Osseointegrated prosthesis.

Main Outcome Measures

Questionnaire for Persons with Transfemoral Amputation (Q-TFA), Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical functioning (PF) and physical component summary (PCS), SF-6D, and Physiological Cost Index (PCI).

Results

At 2 years postimplantation, 6 of 7 Q-TFA scores improved (P<.0001) compared with baseline (prosthetic use, mobility, problem, global, capability, walking habits). The walking aid subscore did not improve (P=.327). Of the 39 participants, increased prosthesis use was reported by 26, same amount of use by 11, and less use by 2. Improvement was reported in 16 of the 30 separate problem items (P<.05). Unchanged items included problems regarding phantom limb pain and pain from the back, shoulders, and contralateral limb. The PF, PCS, and SF-6D improved a mean of 24.1±21.4 (P<.0001), 8.5±9.7 (P<.0001), and .039±.11 (P=.007) points, respectively. Walking energy cost decreased (mean PCI at baseline, .749; mean PCI at follow-up, .61; P<.0001).

Conclusions

Two years after intervention, patients with a unilateral TFA treated with an OPRA implant showed important improvements in prosthetic function and physical quality of life. However, walking aids used and the presence of phantom limb pain and pain in other extremities were unchanged. This information is valuable when considering whether percutaneous osseointegrated prostheses are a relevant treatment option.

Section snippets

Methods

The OPRA treatment involves 2 surgeries 6 months apart, followed by a careful increase in implant loading and prosthetic activity over at least 6 months, resulting in a treatment period of about 1 year.7, 18 The OPRA study is composed of 51 patients treated with 55 implants (n=45 unilateral TFA, n=6 bilateral TFA of whom 4 were treated bilaterally) enrolled in the study from 1999 through 2007. Specific demographics have previously been described.¹⁸ The OPRA study protocol comprises assessments

Results

The results showed that 6 of 45 subjects with a unilateral TFA were not followed for 2 years for varying reasons (implant removed because of complications: n=3, deceased: n=1, lost to follow-up: n=1, withdrawn because of problems with contralateral limb: n=1).¹⁸ As a result, the data reported in this study are based on 39 subjects (17 men, 22 women) with unilateral TFA. The amputation was the result of trauma (n=23), tumor (n=11), or other cause (n=5). The mean age at amputation was 31±14.8

Discussion

This prospective study focused on individuals with a unilateral TFA treated with osseointegration and followed for 2 years. The results confirm earlier publications reporting that patients treated with the OPRA show important improvements with regard to prosthetic mobility and HRQOL.13, 14 In the evaluation of whether or not a bone-anchored prosthesis is an adequate treatment alternative, the patient should be given detailed realistic information, including possible benefits and complications.

Conclusions

This prospective study showed increased and large-scale daily prosthesis use, reduced problems, improved mobility, including more walking and decreased energy cost, and improved physical HRQOL in individuals with a unilateral TFA treated with the OPRA implants and followed over 2 years. However, there was no significant change in use of walking aids, trouble reported with regard to phantom limb pain, and pain problems from the back, shoulders, and contralateral limb compared with baseline.

Suppliers

a.
Integrum AB, Krokslätts Fabriker 50, 43137 Mölndal, Sweden.
b.
IBM Corp, 1 New Orchard Rd, Armonk, NY 10504-1722.

Acknowledgment

We thank Eva Häggström, CPO, Department for Prosthetics and Orthotics, Sahlgrenska University Hospital, for collection of data regarding prosthetic components.

References (45)

H. Van de Meent et al.
Walking ability and quality of life in subjects with transfemoral amputation: a comparison of osseointegration with socket prostheses
Arch Phys Med Rehabil
(2013)
R. Tranberg et al.
Improvements in hip- and pelvic motion for patients with osseointegrated trans-femoral prostheses
Gait Posture
(2011)
J. Brazier et al.
The estimation of a preference-based measure of health from the SF-36
J Health Econ
(2002)
J.G. Penn-Barwell
Outcomes in lower limb amputation following trauma: a systematic review and meta-analysis
Injury
(2011)
D.M. Ehde et al.
Chronic phantom sensations, phantom pain, residual limb pain, and other regional pain after lower limb amputation
Arch Phys Med Rehabil
(2000)
M. Akula et al.
A meta-analysis of amputation versus limb salvage in mangled lower limb injuries–the patient perspective
Injury
(2011)
R. Branemark et al.
Osseointegration in skeletal reconstruction and rehabilitation: a review
J Rehabil Res Dev
(2001)
H.H. Aschoff et al.
Transcutaneous, distal femoral, intramedullary attachment for above-the-knee prostheses: an endo-exo device
J Bone Joint Surg Am
(2010)
K. Hagberg et al.
Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems
Prosthet Orthot Int
(2001)
T.R. Dillingham et al.
Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study
Am J Phys Med Rehabil
(2001)

R.A. Sherman

Utilization of prostheses among US veterans with traumatic amputation: a pilot survey

J Rehabil Res Dev

(1999)

R. Gailey et al.

Unilateral lower-limb loss: prosthetic device use and functional outcomes in servicemembers from Vietnam war and OIF/OEF conflicts

J Rehabil Res Dev

(2010)

K. Hagberg et al.

One hundred patients treated with osseointegrated transfemoral amputation prostheses–rehabilitation perspective

J Rehabil Res Dev

(2009)

K. Hagberg et al.

Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort

Prosthet Orthot Int

(2005)

J. Sullivan et al.

Rehabilitation of the transfemoral amputee with an osseointegrated prosthesis: the United Kingdom experience

Prosthet Orthot Int

(2003)

E.E. Haggstrom et al.

Comparison of prosthetic costs and service between osseointegrated and conventional suspended transfemoral prostheses

Prosthet Orthot Int

(2013)

S. Jonsson et al.

Osseointegration amputation prostheses on the upper limbs: methods, prosthetics and rehabilitation

Prosthet Orthot Int

(2011)

K. Hagberg et al.

Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up

Prosthet Orthot Int

(2008)

M. Lundberg et al.

My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb

Prosthet Orthot Int

(2011)

J.L. Frossard et al.

Functional outcome of transfemoral amputees fitted with an osseointegrated fixation: temporal gait characteristics

J Prosthet Orthot

(2010)

L. Frossard et al.

Monitoring of the load regime applied on the osseointegrated fixation of a trans-femoral amputee: a tool for evidence-based practice

Prosthet Orthot Int

(2008)

R. Branemark et al.

A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: a prospective study of 51 patients [published erratum appears in Bone Joint J 2014;96-B-562]

Bone Joint J

(2014)

Cited by (91)

Oxygen consumption and gait dynamics in transfemoral bone-anchored prosthesis users compared to socket-prosthesis users: A cross-sectional study
2023, Gait and Posture
A transfemoral bone-anchored prosthesis (BAP) is an alternative for the conventional socket-suspended prosthesis (SSP) in persons suffering from socket-related problems. In these persons, it has been demonstrated to reduce oxygen consumption during walking, which could be related to centre of mass (CoM) and trunk dynamics. However, it remains uncertain whether the same comparative findings are found in SSP-users without any socket-related problems.
Do oxygen consumption, CoM and trunk dynamics during walking differ between satisfied transfemoral SSP- and BAP-users and able-bodied individuals (AB); and are CoM and trunk dynamics and pistoning potential determinants of oxygen consumption?
Oxygen consumption was measured while participants walked on a treadmill at preferred speed, 30 % slower, and 30 % faster. At preferred speed, we also evaluated CoM deviation, root-mean-square values (RMS) of mediolateral (ML) CoM and trunk excursions, and pistoning. In the prosthetic users, we evaluated whether oxygen consumption, CoM and trunk dynamics, and pistoning were associated.
We included BAP-users (n = 10), SSP-users (n = 10), and AB (n = 10). SSP-users demonstrated higher oxygen consumption, CoM and trunk RMS ML in comparison to AB during walking. BAP-users showed intermediate results between SSP-users and AB, yet not significantly different from either group. Greater CoM and trunk excursions were associated with higher oxygen consumption; in the SSP-users a greater degree of pistoning, in turn, was found to associate with larger trunk RMS ML.
Our results indicate that satisfied SSP-users have increased oxygen consumption compared to AB subjects and use compensatory movements during walking. An assessment of CoM and trunk dynamics, and pistoning during walking may be considered for evaluating whether an individual SSP-user could possibly benefit from a BAP, in addition to the currently used functional tests for evaluating eligibility. This might lead to a larger group of persons with a transfemoral SSP benefiting from this technology.
Osseointegrated prostheses for the rehabilitation of patients with transfemoral amputations: A prospective ten-year cohort study of patient-reported outcomes and complications
2023, Journal of Orthopaedic Translation
Citation Excerpt :
Since 1999, the so-called OPRA study has followed 51 patients treated with 55 implants and reported prospective short-term (two years) [6] and mid-term (five years) [7] results. Other studies have reported on the benefits [8–11] and complications [10,12,13] following OPRA treatment. Considered together, the findings have shown large and important improvements in everyday life, mobility and HRQoL, accompanied by Adverse events (AEs) in terms of infection and other implant complications.
Osseointegrated implants for patients with transfemoral amputations (TFAs) are a novel treatment under development, and prospective long-term evidence is lacking. The objectives were to determine patient-reported outcomes (PROs) and complications after ten years compared to before treatment and to compare the first five-year period with the later five-year period with regard to the outcomes.
In a nonrandomized, prospective cohort study, patients with TFAs treated between 1999 and 2007 with the Osseointegrated Prosthesis for the Rehabilitation of Amputees (OPRA) system (n = 51) (28 men/23 women; mean age at amputation: 32 years old; mean age at treatment: 44 years old in a single university hospital were followed for ten years. PROs included the Questionnaire for Persons with a Transfemoral Amputation (Q-TFA, four scores 0–100) and the Short Form 36 Health Survey (SF-36, ten scores 0–100) and were answered before treatment and until the ten-year follow-up after treatment. Analyses of differences in PRO scores were conducted using Wilcoxon's signed rank test. The implant survival and revision-free rates with respect to adverse events (implant revision, mechanical complications, and deep infections) were presented as Kaplan–Meier graphs with 95% confidence intervals (CIs). The incidences of events per ten and five person-years were calculated. Spearman's correlation analysis was used for analyses of associations between adverse events.
PROs showed statistically significant mean improvements between baseline and the ten-year follow-up with regard to all Q-TFA scores: the prosthetic use score (+36), prosthetic mobility score (+18), problem score (−28) and global score (+38) (all p < 0.001), and the SF-36 physical functioning score (+26, p < 0.001) and physical component score (+6, p < 0.01). No PROs showed a statistically significant deterioration. Over the ten years, 12 patients were lost (one lost to follow-up, one dropped out of the study, two died, and eight had implants removed (four before five years and four between five and ten years). At ten years, the revision-free survival rates were 83% (CI: 69%–91%), 65% (CI: 49%–77%) and 17% (CI: 7%–29%) for implant revision, deep infection and mechanical complications, respectively. Mechanical complications, 3.9 per 10 person-years (CI: 2.2–5.1) constituted the most common serious adverse event and were more common during the last five years than during the first five years (p < 0.001). No significant difference in the incidence of deep infections was observed between the earlier and the later five-year periods: 0.3 per 5 person-years (CI: 0.1–0.5) vs. 0.3 per person-years (CI: 0.1–0.5) (p = 0.740). Correlation analyses between the earlier and later five years revealed a positive association between deep infections and implant removal (0.57, p < 0.001) and between mechanical complications and adverse events (0.65, p < 0.001).
Improved PROs were demonstrated ten years after the introduction of a novel principle for bone anchorage of amputation prostheses. Nevertheless, an increasing rate of mechanical complications is of concern.
Osseointegration Following Transfemoral Amputation After Infected Total Knee Replacement: A Case Series of 10 Patients With a Mean Follow-up of 5 Years
2022, Arthroplasty Today
Management of total knee replacement (TKR) infection may sometimes prompt knee fusion (KF) or transfemoral amputation (TFA), both associated with low mobility and quality of life (QOL). Transcutaneous osseointegration for amputees provides superior mobility and QOL vs traditional socket prostheses but has not been studied for patients with a history of infected TKR. This study investigates the following hypothesis: Patients who have had TFA or KF following infected TKR achieve better mobility and QOL following transfemoral osseointegration.
A retrospective evaluation of the prospectively maintained registry identified 10 patients who had prior infected TKR. The mobility assessments (patient daily prosthesis wear time, K-level, Timed Up and Go, 6-Minute Walk Test) and QOL surveys (Questionnaire for Persons with a Transfemoral Amputation Global, Mobility, and Problem scores) were compared preoperatively and after at least 2 years. Complications requiring an additional surgery were also evaluated.
Daily wear hours, K-level, and 6-Minute Walk Test and Questionnaire for Persons with a Transfemoral Amputation Global and Problem scores significantly improved (P < .05). Through 1 year, 4 patients (40%) had additional surgeries. After several years, 7 patients (70%) had at least 1 additional surgery, and 5 (50%) had multiple, for an average of 1 debridement and 1.3 soft-tissue refashionings per patient. One patient died of newly diagnosed cancer 1 year after transcutaneous osseointegration for amputees.
Transfemoral osseointegration confers significantly better mobility and QOL vs KF or a TFA with traditional socket prostheses following infected TKR. Technique improvements to prevent subsequent surgeries may provide an increasingly streamlined experience.
The effect of cortical thickness and thread profile dimensions on stress and strain in bone-anchored implants for amputation prostheses
2022, Journal of the Mechanical Behavior of Biomedical Materials
Skeletal attachment of limb prostheses ensures load transfer between the prosthetic leg and the skeleton. For individuals with lower limb amputation, these loads may be of substantial magnitude. To optimize the design of such systems, knowledge about the structural interplay between implant design features, dimensional changes, and material properties of the implant and the surrounding bone is needed. Here, we present the results from a parametric finite element investigation on a generic bone-anchored implant system of screw design, exposed to external loads corresponding to average and high ambulatory loading. Of the investigated parameters, cortical thickness had the largest effect on the stress and strain in the bone-anchored implant and in the cortical bone. 36%–44% reductions in maximum longitudinal stress in the bone-anchored implant was observed as a result of increased cortical thickness from 2 mm to 5 mm. A change in thread depth from 1.5 mm to 0.75 mm resulted in 20%–22% and 10%–18% reductions in maximum longitudinal stress in the bone-anchored implant at 2 mm and 5 mm cortical thickness respectively. The effect of changes in the thread root radius was less prominent, with 8% reduction in the maximum longitudinal stress in the bone-anchored implant being the largest observed effect, resulting from an increased thread root radius from 0.1 mm to 0.5 mm at a thread depth of 1.5 mm. Autologous transplantation of bone tissue distal to the fixture resulted in reductions in the longitudinal stress in the percutaneous abutment. The observed stress reduction of 10%–31% was dependent on the stiffness of the transplanted bone graft and the cortical thickness of surrounding bone. Results from this investigation may guide structural design optimization for bone-anchored implant systems for attachment of limb prostheses.
Low plasticity burnishing improves fretting fatigue resistance in bone-anchored implants for amputation prostheses
2022, Medical Engineering and Physics
Citation Excerpt :
In 1999, this implant system was CE marked and standardized along with its surgical technique and rehabilitation protocol for transfemoral amputations. Since then, prospective clinical trials have shown that treatment with the OPRA Implant System leads to increased quality of life, increased prosthetic usage, improved mobility and reduced prosthesis related problems compared with conventional socket prostheses [10–12]. Similar findings have been reported with other implants for skeletal attachment of limb prostheses [13–15].
Fretting fatigue is a common problem for modular orthopedic implants which may lead to mechanical failure of the implant or inflammatory tissue responses due to excessive release of wear debris. Compressive residual stresses at the contacting surfaces may alleviate the problem. Here we investigate the potential of a surface enhancement method known as low plasticity burnishing (LPB) to increase the fretting fatigue resistance of bone-anchored implants for skeletal attachment of limb prostheses. Rotation bending fatigue tests performed on LPB treated and untreated test specimens demonstrate that the LPB treatment leads to statistically significantly increased resistance to fretting fatigue (LPB treated test specimens withstood on average 108,780 load cycles as compared with 37,845 load cycles for untreated test specimens, p = 0.004). LPB treated test specimens exhibited less wear at the modular interface as compared with untreated test specimens. This surface treatment may lead to reduced risk of fretting induced component failure and a reduced need for revision of implant system componentry.
Lifetime cost-effectiveness analysis osseointegrated transfemoral versus socket prosthesis using Markov modelling
2024, Bone and Joint Open

View all citing articles on Scopus

: Supported in part by an ALF grant from Sahlgrenska University Hospital (grant no. ALF-GBG-138721), Promobila Foundation, Jimmy Dahlsten Fund, and Johan Jansson Foundation, all from Sweden.

: Disclosures: Brånemark is a shareholder in the Integrum Company. No benefits in any form have been received directly or indirectly to the subject of this article. The other authors have nothing to disclose.

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Original articleOutcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up

Abstract

Objective

Design

Setting

Participants

Intervention

Main Outcome Measures

Results

Conclusions

Section snippets

Methods

Results

Discussion

Conclusions

Suppliers

Acknowledgment

Arch Phys Med Rehabil

Gait Posture

J Health Econ

Injury

Arch Phys Med Rehabil

Injury

Osseointegration in skeletal reconstruction and rehabilitation: a review

J Rehabil Res Dev

Transcutaneous, distal femoral, intramedullary attachment for above-the-knee prostheses: an endo-exo device

J Bone Joint Surg Am

Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems

Prosthet Orthot Int

Use and satisfaction with prosthetic devices among persons with trauma-related amputations: a long-term outcome study

Am J Phys Med Rehabil

Utilization of prostheses among US veterans with traumatic amputation: a pilot survey

J Rehabil Res Dev

Unilateral lower-limb loss: prosthetic device use and functional outcomes in servicemembers from Vietnam war and OIF/OEF conflicts

J Rehabil Res Dev

One hundred patients treated with osseointegrated transfemoral amputation prostheses–rehabilitation perspective

J Rehabil Res Dev

Socket versus bone-anchored trans-femoral prostheses: hip range of motion and sitting comfort

Prosthet Orthot Int

Rehabilitation of the transfemoral amputee with an osseointegrated prosthesis: the United Kingdom experience

Prosthet Orthot Int

Comparison of prosthetic costs and service between osseointegrated and conventional suspended transfemoral prostheses

Prosthet Orthot Int

Osseointegration amputation prostheses on the upper limbs: methods, prosthetics and rehabilitation

Prosthet Orthot Int

Osseointegrated trans-femoral amputation prostheses: prospective results of general and condition-specific quality of life in 18 patients at 2-year follow-up

Prosthet Orthot Int

My prosthesis as a part of me: a qualitative analysis of living with an osseointegrated prosthetic limb

Prosthet Orthot Int

Functional outcome of transfemoral amputees fitted with an osseointegrated fixation: temporal gait characteristics

J Prosthet Orthot

Monitoring of the load regime applied on the osseointegrated fixation of a trans-femoral amputee: a tool for evidence-based practice

Prosthet Orthot Int

A novel osseointegrated percutaneous prosthetic system for the treatment of patients with transfemoral amputation: a prospective study of 51 patients [published erratum appears in Bone Joint J 2014;96-B-562]

Bone Joint J

Original article
Outcome of Percutaneous Osseointegrated Prostheses for Patients With Unilateral Transfemoral Amputation at Two-Year Follow-Up