Kerstin Hagberg

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

Individuals with unilateral trans-femoral amputations due to non-vascular causes were studied in a mailed survey designed to investigate health-related quality of life (HRQL), prosthetic use and problems. The Swedish SF-36 Health Survey and a structured questionnaire designed for trans-femoral amputees were used. The series consisted of 97 subjects (60 men, 37 women), aged 20 to 69 years with a mean of 22 years since the amputation. Trauma was the cause of amputation in 55%, tumour in 35% and other causes in 10%. Ninety-two (92) subjects (95%) had a prosthesis and 80 (82%) used it daily. General HRQL was significantly lower than Swedish age- and gender-matched norms in all dimensions as measured by SF-36. Most frequently reported problems that had led to reduction in quality of life were heat/sweating in the prosthetic socket (72%), sores/skin irritation from the socket (62%), inability to walk in woods and fields (61%) and inability to walk quickly (59%). Close to half were troubled by stump pain (51%), phantom limb pain (48%), back pain (47%) and pain in the other leg (46%). One fourth considered themselves to have a poor or extremely poor overall situation. Trans-femoral amputation, due to non-vascular causes, has an evident impact on quality of life and there are considerable problems related to the amputation and the prosthesis. Efforts to improve the physical and the psychological well-being for this group, with a long life expectancy, are needed.

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

This is the first report on prospective outcome for individuals treated with bone-anchored trans-femoral amputation prostheses (OI-prostheses) using the method of osseointegration. The aim was to analyze general and condition-specific health related quality of life (HRQL) at 2-year follow-up as compared to the preoperative situation. The study population consists of the first 18 consecutively treated patients (8 male/10 female, mean age 45 years) in a clinical investigation with amputations mainly caused by trauma and tumour. At inclusion the mean time since the amputation was 15 years (10 months – 33 years). Two self-report questionnaires were answered preoperatively and at follow-up: the SF-36 Health Survey (SF-36) and the Questionnaire for persons with a Transfemoral Amputation (Q-TFA). At follow-up 17/18 patients used the OI-prosthesis; one did not due to pain and loosening of the implant. Four of the scales of the SF-36 (Physical Functioning, Role Functioning Physical, Bodily Pain and Physical Component Score) and all four scores of Q-TFA (Prosthetic Use, Prosthetic Mobility, Problems and Global Health) were statistically significantly improved at follow-up showing superior general physical HRQL, increased prosthetic use, better prosthetic mobility, fewer problems and a better global amputation situation. Thus, osseointegrated prostheses represent a promising development in the rehabilitation of individuals with transfemoral amputation and increase their quality of life.

Socket Versus Bone-Anchored Trans-Femoral Prostheses: Hip Range of Motion and Sitting Comfort:

This is the first study to report on hip range of motion (ROM) among active prosthesis users, when wearing and not wearing a trans-femoral socket prosthesis and to compare with individuals rehabilitated with an osseointegrated bone-anchored prosthesis. In addition, discomfort when sitting with the prosthesis is reported in both groups. The study group all had a non-vascular amputation and were divided into those supplied with a socket prosthesis (S group) (n = 43, mean age 51 years, 74% men) or a bone-anchored prosthesis (OI group) (n = 20, mean age 46 years, 75% men). Active hip ROM was measured with a goniometer, and self-reported problems with discomfort when sitting were recorded. The hip motion decreased in all directions when wearing the socket prosthesis compared to without it (P < 0.001 for all directions), and 37% of the subjects had less than 90° of hip flexion when wearing their prosthesis. Discomfort when sitting was reported among 44% (n = 19) in the S group and was more common among individuals with less than 90° of hip flexion motion (P = 0.025). In the OI group, no restriction in hip motion was measured with the prosthesis, and no subject had less than 90° of flexion and 5% (n = 1) reported discomfort when sitting. This study shows that a trans-femoral prosthetic socket significantly reduces the ROM of the hip and that discomfort when sitting is common among individuals wearing such prostheses. Further, the study confirms that individuals using a bone-anchored prosthesis have no restricted hip motion with the prosthesis and report very few problems with discomfort when sitting.

Questionnaire for Persons with a Transfemoral Amputation (Q-TFA): initial validity and reliability of a new outcome measure.

The Questionnaire for Persons with a Transfemoral Amputation (Q-TFA) is a new self-report measure developed for nonelderly transfemoral amputees using a socket- or osseointegrated prosthesis to reflect use, mobility, problems, and global health, each in a separate score (0-100). This paper describes the initial measurement properties of the Q-TFA as completed by 156 persons with a transfemoral amputation using a socket prosthesis (67% male, 92% nonvascular cases, mean age 51 years). Criterion validity was determined by associations between scores of the Q-TFA and the Short-Form 36 (SF-36)-Item Health Survey. Reliability was assessed by retest (n = 48) and by determination of the internal consistency. Correlations between Q-TFA and SF-36-Item Health Survey scales matched hypothesized patterns. Intraclass correlations were between 0.89 and 0.97, and measurement error ranged from 10 to 19 points. Cronbachs alpha revealed good internal consistency, with no values less than 0.7. This study shows that the Q-TFA, applied to persons using a transfemoral socket prosthesis, has adequate initial validity and reliability.

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

Background: Bone-anchored prosthesis is still a rather unusual treatment for patients with limb loss. Objectives: The aim of this study was to improve our understanding about the experience of living with an osseointegrated prosthesis (OI-prosthesis) compared to one suspended with a socket, through the use of qualitative research methodology. Study design: A qualitative phenomenological research method. Methods: Thirteen Swedish patients (37–67 years) with unilateral upper or lower limb amputation (10 transfemoral, 2 transhumeral, 1 transradial), who had been using OI-prostheses for 3 to 15 years, were recruited by means of purposive sampling. An audio-taped in-depth interview was performed. The guiding question was ‘How do you experience living with your osseointegrated prosthesis compared to your earlier prostheses suspended with sockets?’. The empirical phenomenological psychological method was used for data analysis. Results: The results showed that all participants described living with an OI-prosthesis as a revolutionary change. These experiences were described in terms of three typologies, called ‘Practical prosthesis’, ‘Pretend limb’ and ‘A part of me’. Conclusions: The most important finding was that the change went beyond the functional improvements, integrating the existential implications in the concept of quality of life. Clinical relevance This qualitative in-depth interview study on patients using bone-anchored prosthetic limbs showed that all described a revolutionary change in their lives as amputees and the meaning of that change went beyond the functional improvements, integrating existential implications in the concept of quality of life.

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

This study aimed to provide a description of the continuous recording of the true load regime experienced during daily living by the abutment of a trans-femoral amputee fitted with an osseointegrated fixation. The specific objectives: (i) To present an apparatus and a procedure allowing recording of the load regime, and (ii) an example of the raw data and six performance indicators of the usage of the prosthesis obtained with this method. A subject was monitored for a period of 5 hours as he went about his daily activities. The load regime was directly measured and recorded using a commercial transducer and data logger. The overall load profile presented alternative periods of variable length of inactivity (64%) and activity (36%), respectively. The maximum load applied on the mediolateral, anteroposterior and the long axes represented 21%, 21% and 120% of the body weight, respectively. The anteroposterior, mediolateral and long components of the impulse were 395 kN.s, 359 kN.s and 2,323 kN.s, respectively. The amputee generated a total of 2312 gait cycles of the prosthetic leg, giving an approximate overall cadence of 8 stride/min. Preliminary outcomes indicated that the proposed method was an improvement on the current techniques as it provided the true loading and actual usage of the prosthesis during daily living. This study is a stepping stone in the development of future affordable, on-board and user-friendly load recording systems that can be used in evidence-based practice.

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

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 ± 12.4 y) 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.

Apparatus for monitoring load bearing rehabilitation exercises of a transfemoral amputee fitted with an osseointegrated fixation: A proof-of-concept study

The purpose of this proof-of-concept study was to determine the relevance of direct measurements to monitor the load applied on the osseointegrated fixation of transfemoral amputees during static load bearing exercises. The objectives were (A) to introduce an apparatus using a three-dimensional load transducer, (B) to present a range of derived information relevant to clinicians, (C) to report on the outcomes of a pilot study and (D) to compare the measurements from the transducer with those from the current method using a weighing scale. One transfemoral amputee fitted with an osseointegrated implant was asked to apply 10 kg, 20 kg, 40 kg and 80 kg on the fixation, using self-monitoring with the weighing scale. The loading was directly measured with a portable kinetic system including a six-channel transducer, external interface circuitry and a laptop. As the load prescribed increased from 10 kg to 80 kg, the forces and moments applied on and around the antero-posterior axis increased by four-fold anteriorly and 14-fold medially, respectively. The forces and moments applied on and around the medio-lateral axis increased by nine-fold laterally and 16-fold from anterior to posterior, respectively. The long axis of the fixation was overloaded and underloaded in 17% and 83% of the trials, respectively, by up to + or - 10%. This proof-of-concept study presents an apparatus that can be used by clinicians facing the challenge of improving basic knowledge on osseointegration, for the design of equipment for load bearing exercises and for rehabilitation programs.

Vibrotactile evaluation: osseointegrated versus socket-suspended transfemoral prostheses.

This study investigated detection thresholds of vibrometric stimuli in patients with transfemoral amputation supplied with osseointegrated (OI) and socket-suspended prostheses. It included 17 patients tested preoperatively with socket-suspended prostheses and after 2 yr with OI prostheses and a control group (n = 17) using socket-suspended prostheses, evaluated once. Assessments on the prosthetic and intact feet were conducted at six frequencies (8, 16, 32, 64, 125, and 250 Hz). Furthermore, measurements were conducted to investigate how vibrometric signals are transmitted through a test prosthesis. The results showed that the OI group had improved ability to detect vibrations through the prosthesis at 125 Hz (p = 0.01) at follow-up compared with the preoperative measurement. Compared with the control group, the OI group at follow-up had better ability to detect high frequency vibrations through the prosthesis (125 Hz, p = 0.02; 250 Hz, p = 0.03). The vibrometric signal transmitted through the test prosthesis was reduced at 8, 125, and 250 Hz but was amplified at 16, 32, and 64 Hz. Differences between the OI and the control groups were found in the highest frequencies in which the test prosthesis showed reduction of the vibrometric signal. The study provides insight into the mechanisms of vibration transmission between the exterior and bone-anchored as well as socket-suspended amputation prostheses.

Load-Relief of Walking Aids on Osseointegrated Fixation: Instrument for Evidence-Based Practice

Clinicians are currently in demand of tools enabling individual assessment during their daily practice of load-relief of walking aids. The first aim of this article is to describe a portable kinetic system that could be used to measure directly the true load applied on the residuum during assisted walking. The second aim is to present the information that can be derived from the raw loading data. The third aim is to provide an example for a participant. One active transfemoral amputee fitted with an osseointegrated fixation was asked to walk in straight level line with no aid, one stick, one and two elbow crutches on a 20 m walkway. The load-relief was measured using a six-channel transducer and recorded using a data logger. The overall loading was decreased by 2% using one stick, 5% using one crutch and by 10% using two crutches. This study presents a method that can be used by clinicians facing the challenge of prescribing and assessing walking aids to restore the locomotion of lower limb amputees in the framework of an evidence-based practice.