Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?

BACKGROUND: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events. QUESTIONS/PURPOSES: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture? METHODS: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death. RESULTS: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention. CONCLUSION: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant. LEVEL OF EVIDENCE: Level III, therapeutic study.

What Are the Risk Factors for Mechanical Failure and Loosening of a Transfemoral Osseointegrated Implant System in Patients with a Lower-limb Amputation?

BACKGROUND: Septic loosening and stem breakage due to metal fatigue is a rare but well-known cause of orthopaedic implant failure. This may also affect the components of the osseointegrated implant system for individuals with transfemoral amputation who subsequently undergo revision. Identifying risk factors is important to minimize the frequency of revision surgery after implant breakage. QUESTIONS/PURPOSES: (1) What proportion of patients who received an osseointegrated implant after transfemoral amputation underwent revision surgery, and what were the causes of those revisions? (2) What factors were associated with revision surgery when stratified by the location of the mechanical failure and (septic) loosening (intramedullary stem versus dual cone adapter)? METHODS: Between May 2009 and July 2015, we treated 72 patients with an osseointegrated implant. Inclusion criteria were a minimum follow-up of 5-years and a standard press-fit cobalt-chromium-molybdenum (CoCrMb) transfemoral osseointegrated implant. Based on that, 83% (60 of 72) of patients were eligible; a further 3% (2 of 60) were excluded because of no received informed consent (n = 1) and loss to follow-up (n = 1). Eventually, we included 81% (58 of 72) of patients for analysis in this retrospective, comparative study. We compared patient characteristics (gender, age, and BMI), implant details (diameter of the intramedullary stem, length of the dual cone, and implant survival time), and event characteristics (infectious complications and distal bone resorption). The data were retrieved from our electronic patient file and from our cloud-based database and analyzed by individuals not involved in patient care. Failures were categorized as: (1) mechanical failures, defined as breakage of the intramedullary stem or dual-cone adapter, or (2) (septic) loosening of the osseointegrated implant. RESULTS: Thirty-four percent (20 of 58) of patients had revision surgery. In 12% (7 of 58) of patients, the reason for revision was due to intramedullary stem failures (six breakages, one septic loosening), and in 22% (13 of 58) of patients it was due to dual-cone adaptor failure (10 weak-point breakages and four distal taper breakages; one patient broke both the weak-point and the dual-cone adapter). Smaller median stem diameter (failure: 15 mm [interquartile range 1.3], nonfailure: 17 mm [IQR 2.0], difference of medians 2 mm; p < 0.01) and higher median number of infectious events (failure: 6 [IQR 11], nonfailure: 1 [IQR 3.0], difference of medians -5; p < 0.01) were associated with revision intramedullary stem surgery. No risk factors could be identified for broken dual-cone adapters. CONCLUSION: Possible risk factors for system failure of this osteointegration implant include small stem diameter and high number of infectious events. We did not find factors associated with dual-cone adapter weak-point failure and distal taper failure, most likely because of the small sample size. When treating a person with a lower-limb amputation with a CoCrMb osseointegrated implant, we recommend avoiding a small stem diameter. Further research with longer follow-up is needed to study the success of revised patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Effect of elective neck dissection versus sentinel lymph node biopsy on shoulder morbidity and health-related quality of life in patients with oral cavity cancer: A longitudinal comparative cohort study.

OBJECTIVE: To research the difference in shoulder morbidity and health-related quality of life between patients with cT1-2N0 oral cavity squamous cell carcinoma that undergo either elective neck dissection (END) or a sentinel lymph node biopsy (SLNB) based approach of the neck. MATERIALS AND METHODS: A longitudinal study with measurements before surgery, 6 weeks, 6 months, and 12 months after surgery. Shoulder morbidity were determined with measurements of active range of motion of the shoulder and patient-reported outcomes for shoulder morbidity (SDQ, SPADI) and health-related quality of life (HR-QoL) (EQ5D, EORTC-QLQ-HN35). Linear mixed model analyses were used to analyze differences over time between patients that had END, SLNB or SLNB followed by complementing neck dissection. RESULTS: We included 69 patients. Thirty-three patients were treated with END. Twenty-seven patients had SLNB without complementing neck dissection (SLNB), and nine were diagnosed lymph node positive followed by completion neck dissection (SLNB + ND). Ipsilateral shoulder abduction (P = .031) and forward flexion (P = .039) were significantly better for the SLNB group at 6 weeks post-intervention compared to the END and SLNB + ND group. No significant differences for shoulder morbidity, or health-related quality of life were found at 6 weeks, 6 months, and 12 months between the three groups. CONCLUSION: With oncologic equivalence for the END and SLNB as strategies for the cN0 neck already demonstrated, and the SLNB being more cost-effective, our demonstrated benefit in short-term shoulder function strengthens the choice for the SLNB as a preferred treatment strategy.

Identifying unmet needs and limitations in physical health in survivors of Head and Neck Cancer.

OBJECTIVE: To gain insight into the level of unmet needs and limitations in physical health experienced by survivors of head and neck cancer, and to evaluate whether unmet needs in physical health and limitations in physical performance are associated. MATERIALS AND METHODS: In this cross-sectional study, unmet needs were measured with Supportive Care Needs Surveys (SCNS-SF34, SCNS-HNC). Limitations in physical health were measured for maximal mouth opening, neck and shoulder function, hand grip strength and lower body strength, level of mobility and walking ability. RESULTS: The SCNSs showed that 48% had a cancer generic unmet need and 46% had at least one HNC-specific unmet need. In total, 76% of sHNC had a cancer generic limitation in physical health and that 58% had an HNC-specific limitation in the mobility of neck and shoulders or maximum mouth opening. The domain of physical and daily living needs showed a weak association with lateral flexion of the neck to the left (R = -0.319; p = 0.024). CONCLUSION: Survivors of HNC might benefit from the use of both SCNSs and physical performance measurements during usual care follow-up for early and optimal identification of unmet needs and limitations in physical health.

Reproducibility of measurements on physical performance in head and neck cancer survivors; measurements on maximum mouth opening, shoulder and neck function, upper and lower body strength, level of physical mobility, and walking ability.

BACKGROUND: Survivors of Head and Neck Cancer experience specific problems in functional performance. The aim of this study was to obtain the test-retest reliability of measurements on Maximal Mouth Opening (MMO), shoulder and neck function, lower and upper body strength, level of mobility and walking ability. MATERIALS AND METHODS: Test-retest study design. Measurements on MMO (intra- and extra orally), Active range of motion of shoulders and neck, 30 Seconds Chair Stand Test, Grip Strength, Timed Up and Go test, and Six Minute Walk test. RESULTS: In total 50 participants were included. The mean age was 68.6. ± 9.9 years and median time since end of treatment was 3.0 years (Q1-Q3: 1.0-5.25 years). We found good to excellent test-retest reliability on the core set of measurements (Intraclass Correlation Coefficient (ICC) 0.77 to 0.98). Measurement of MMO with cardboard card, forward flexion shoulder and Six Minute Walk test had a relatively small measurement error (Smallest Detectable Change (SDC) % 5.4% - 15.1%). Measurement of MMO with a caliper, shoulder abduction, shoulder external rotation, later flexion and rotation of the neck, grip strength, 30 Seconds Chair Stand Test, and Timed up and Go test had a relatively large measurement error (SDC% 19.8% - 44.7%). CONCLUSION: This core set of measurements on physical performance is found reliable and therefore able to differentiate in physical performance. The reported measurement errors should be taken into consideration when interpreting the results of repeated measurements. IMPLICATIONS FOR CANCER SURVIVORS: A core set of physical measurements can be used to measure physical performance in survivors of Head and Neck Cancer.

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

OBJECTIVES:: (1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events. DESIGN:: Prospective cohort study. SETTING:: University medical centre. SUBJECTS:: A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016. INTERVENTION:: Osseointegration implant surgery followed by a predefined rehabilitation programme. MAIN MEASURES:: Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events. RESULTS:: Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ⩽ 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ⩾ 0.038) and back pain ( P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users. CONCLUSION:: Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

Gait symmetry and hip strength in women with developmental dysplasia following hip arthroplasty compared to healthy subjects: A cross-sectional study.

INTRODUCTION: Untreated unilateral developmental dysplasia of the hip (DDH) results in asymmetry of gait and hip strength and may lead to early osteoarthritis, which is commonly treated with a total hip arthroplasty (THA). There is limited knowledge about the obtained symmetry of gait and hip strength after the THA. The objectives of this cross-sectional study were to: a) identify asymmetries between the operated and non-operated side in kinematics, kinetics and hip strength, b) analyze if increased walking speed changed the level of asymmetry in patients c) compare these results with those of healthy subjects. METHODS: Women (18-70 year) with unilateral DDH who had undergone unilateral THA were eligible for inclusion. Vicon gait analysis system was used to collect frontal and sagittal plane kinematic and kinetic parameters of the hip joint, pelvis and trunk during walking at comfortable walking speed and increased walking speed. Furthermore, hip abductor and extensor muscle strength was measured. RESULTS: Six patients and eight healthy subjects were included. In the patients, modest asymmetries in lower limb kinematics and kinetics were present during gait, but trunk lateral flexion asymmetry was evident. Patients' trunk lateral flexion also differed compared to healthy subjects. Walking speed did not significantly influence the level of asymmetry. The hip abduction strength asymmetry of 23% was not statistically significant, but the muscle strength of both sides were significantly weaker than those of healthy subjects. CONCLUSIONS: In patients with a DDH treated with an IBG THA modest asymmetries in gait kinematics and kinetics were present, with the exception of a substantial asymmetry of the trunk lateral flexion. Increased walking speed did not result in increased asymmetries in gait kinematics and kinetics. Hip muscle strength was symmetrical in patients, but significantly weaker than in healthy subjects. Trunk kinematics should be included as an outcome measure to assess the biomechanical benefits of the THA surgery after DDH.

Osseointegrated Transtibial Implants in Patients with Peripheral Vascular Disease: A Multicenter Case Series of 5 Patients with 1-Year Follow-up.

BACKGROUND: Osseointegration is an alternative treatment for amputees who are unable to wear or have difficulty wearing a socket prosthesis. Although the majority of limb amputations are due to vascular disease, such amputations have been perceived as a contraindication to osseointegration surgery. We report the outcomes of osseointegrated reconstruction in a series of 5 patients with limb amputation due to peripheral vascular disease. METHODS: Five patients with transtibial amputation and a history of peripheral vascular disease who received an osseointegration implant from 2014 to 2015 were followed for 12 months. Clinical and functional outcomes were assessed, including pain, the amount of time the patient wore the prosthesis, mobility, walking ability, and quality of life. Adverse events, including infection, fracture, implant failure, revision surgery, additional amputation, and death, were monitored and recorded. RESULTS: Five transtibial amputees (56 to 84 years of age) followed for 1 year after osseointegration surgery were included in this case series. The mobility of all patients was improved at the time of follow-up. Three patients were wheelchair-bound prior to the surgery but all 5 were able to walk and perform daily activities at the time of follow-up. Four of the 5 patients were pain-free at 12 months postoperatively, and all 5 were using the osseointegrated prosthesis. Two patients had a single episode of superficial soft-tissue infection. CONCLUSIONS: An osseointegrated implant may be considered a feasible alternative to the conventional socket prosthesis for patients with peripheral vascular disease. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Gait rehabilitation for a patient with an osseointegrated prosthesis following transfemoral amputation.

BACKGROUND: In patients with a transfemoral amputation socket-related problems are associated with reduced prosthetic use, activity, and quality of life. Furthermore, gait asymmetries are present that may explain secondary complaints. Bone-anchored prostheses (BAPs) may help these patients. Two types of BAP are available, screw and press-fit implants. Rehabilitation following surgery for a press-fit BAP is poorly described. PURPOSE: To describe a rehabilitation program designed to minimize compensation strategies and increase activity using a case-report of an active, 70-year-old man with a traumatic transfemoral amputation who had used a socket prosthesis for 52 years and received a press-fit BAP [Endo-Exo Femoral Prosthesis - EEFP]. INTERVENTION: A 13-week physiotherapy program. OUTCOMES: Outcomes were assessed before surgery, at the end of rehabilitation, and six-month and one-year follow-ups. After rehabilitation gait had improved, the patient had more arm movement, more pelvic shift, less hip rotation during swing phase on the prosthetic side, and absence of vaulting on the sound side. Isometric hip abductor strength was 15% higher on the sound side and 16% higher on the prosthetic side, and walking distance increased from 200 m to 1500 m. At the six-month follow-up, the patient had lower back complications and reduced hip abductor strength and walking distance. At one-year follow-up, walking distance had recovered to 1000 m and gait pattern had improved again, with yielding and absence of terminal impact on the prosthetic side. CONCLUSION: The described rehabilitation program may be an effective method of improving gait in patients with an EEFP even after long-term socket usage.

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

BACKGROUND: Patients 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/DESIGN: A 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. DISCUSSION: This study may identify predictors for clinically relevant outcome measures. TRIAL REGISTRATION: NTR5776 . Registered 11 March 2016, retrospectively registered.