The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 94, Issue 14

Scientific Articles | July 18, 2012

The Benefits of Implant Removal from the Foot and Ankle

Ariel A. Williams, MD¹; Daniela M. Witten, PhD²; Rosanna Duester, PhD, MS, PA-C³; Loretta B. Chou, MD³

¹ Department of Orthopaedic Surgery, Johns Hopkins University, 601 North Caroline Street, Baltimore, MD 21287
² Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195
³ Department of Orthopaedic Surgery, Stanford University, 450 Broadway Street, Redwood City, CA 94063. E-mail address for L.B. Chou: lchou@stanford.edu

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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via her institution), from a third party in support of any aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at Stanford University, Redwood City, California

J Bone Joint Surg Am, 2012 Jul 18;94(14):1316-1320. doi: 10.2106/JBJS.J.01756

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Abstract

Background:

Following successful orthopaedic surgical procedures, implant removal is generally not necessary or recommended. However, patients with pain related to implants may benefit from this elective procedure. The foot and ankle may be more symptomatic from retained implants because of weight-bearing activities, shoe wear, and limited soft-tissue cushioning. In such cases, implant removal may provide good and reliable relief of symptoms.

Methods:

A prospective study of sixty-nine patients who underwent elective removal of symptomatic implants from the foot and ankle was undertaken to evaluate the patients’ pain experience. The Short-Form McGill Pain Questionnaire was administered preoperatively and six weeks postoperatively. Postoperatively, patients were also asked whether they would repeat the procedure and whether they were satisfied with the results.

Results:

Patients reported significantly less pain following the procedure, with the average rating of pain on the visual analog scale (VAS) decreasing from 3.06 to 0.88 and the average rating of present pain intensity decreasing from 2.03 to 0.58 (p < 0.05 for both). Sixty-five percent of the patients reported no pain on either measure at six weeks postoperatively. Preoperative pain was correlated with postoperative pain (r = 0.24 and p < 0.05 for VAS, and r = 0.16 and p > 0.05 for present pain intensity).With the small sample size, preoperative and postoperative pain did not show a significant difference on the basis of implant location or patient age or sex. Ninety-four percent of patients said they would repeat the procedure under the same circumstances, and 91% of patients were satisfied with the results.

Conclusions:

Following successful orthopaedic surgical procedures, removal of implants causing symptoms can result in pain relief and a high rate of patient satisfaction.

Level of Evidence:

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Introduction | Materials and Methods | Results | Discussion | References

Following successful orthopaedic surgery, implant removal is a relatively common procedure, constituting approximately 5% of all orthopaedic operations in the United States^1,2. However, the appropriate indications for implant removal are a matter of debate³. While routine implant removal is generally not recommended, it can be a beneficial option for patients who experience pain and other symptoms.

The foot and ankle can be especially symptomatic from retained implants, with patients experiencing considerable pain and functional impairment⁴. In the foot and ankle, limited amounts of subcutaneous tissue and skin cover the implant. Shoe wear can cause pressure and prominence symptoms, and the demands of weight-bearing activities may make implant-related pain even more troublesome. The most common symptoms include soreness overlying the implant, joint movement limitation, and pain related to physical activity⁵. Patients with implant-related pain may benefit from elective implant removal.

Currently, no prospective study in the literature, to our knowledge, has evaluated the patient benefit from implant removal. Also, the results from retrospective studies have been inconsistent. Jacobsen et al. found that 75% of patients who had undergone open reduction of ankle fractures followed by removal of ankle implants that were causing pain reported that their symptoms improved following the removal⁵. However, in a retrospective study of patients undergoing removal of lateral ankle implants because of pain, Brown et al. found that only 50% of patients reported having less pain postoperatively⁴. Furthermore, implant removal is not without risk⁶. Sanderson et al. reported eleven complications in seventy-five patients with ankle fractures who underwent implant removal⁷. Given the pain and disability associated with symptomatic foot and ankle implants, a greater understanding of the risks and benefits of implant removal is necessary to appropriately counsel patients.

The purpose of this study was to characterize the preoperative and postoperative pain experienced by patients undergoing removal of symptomatic implants from the foot and ankle. We hypothesized that patients would have significantly less pain postoperatively than preoperatively.

Materials and Methods

Introduction | Materials and Methods | Results | Discussion | References

Subjects

Following institutional review board approval, seventy-four consecutive patients undergoing implant removal from the foot and ankle were asked to participate in this prospective cohort pain study. All patients gave informed consent to participate in the study. All patients were treated by a single orthopaedic foot and ankle specialist at one hospital, and they had pain related to their implants and pointed to the implant when asked to show the location of their pain. In all subjects, direct palpation of the implant reproduced the symptoms. We excluded patients undergoing removal of implants for Lisfranc and syndesmotic injuries because this is part of the routine surgical treatment of these injuries at our institution. Five patients did not complete the study because they lost their pain survey form, cancelled the procedure, or did not return for follow-up examination. We evaluated the results in sixty-nine patients (one patient underwent two procedures). There were forty-four women and twenty-five men. The average age was 46.4 years (range, seventeen to eighty-five years).

Patients had had metallic implants inserted for a variety of reasons (Table I). The average time from the original procedure to the time of implant removal was 35.6 months (range, four months to thirty-three years). For patients with multiple implants, all implants were removed simultaneously, with the exception of one patient with a tibial plafond fracture who requested that removal of his implants be staged over two procedures. Five patients had broken screws. In all cases, all implant fragments were successfully removed. Four patients had additional procedures performed at the time of implant removal: one posterior tibial tenosynovectomy, one ankle arthroscopy and debridement, one Achilles tendon lengthening, and one bone biopsy for a patient with a history of osteomyelitis. The average procedure length was approximately one hour (range, fifteen to ninety minutes). Fifteen patients had general anesthesia alone, eight patients had regional blocks alone, five patients had general anesthesia combined with regional blocks, thirty-two patients had general anesthesia with local blocks, four patients had monitored anesthesia care with regional blocks, and six patients had monitored anesthesia care with local blocks. One patient who lived far from the hospital was admitted expectantly for pain control and stayed one night. All other patients were discharged home on the day of surgery. Generally, postoperative pain was managed with oral analgesics. The majority of patients were given prescriptions for hydrocodone-acetaminophen postoperatively, except when specific indications existed for the use of alternative medications.

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TABLE I A List of the Preoperative Diagnoses

Diagnosis*	No. of Patients
ORIF bimalleolar fracture	15
ORIF lateral malleolar fracture	14
ORIF calcaneal fracture	7
Ankle fusion	6
Calcaneal osteotomy with posterior tibial tendon reconstruction	5
ORIF multiple fractures	4
Bunionectomy	3
ORIF tibial plafond fracture	3
OATS procedure	2
ORIF fifth metatarsal fracture	2
ORIF distal tibial fracture	2
ORIF trimalleolar fracture	1
Distal tibial osteotomy	1
ORIF talar neck fracture	1
Triple arthrodesis	1
Subtalar arthrodesis	1
Talonavicular arthrodesis and calcaneal osteotomy	1

*Of the four patients who underwent open reduction and internal fixation (ORIF) of multiple fractures, one had a bimalleolar and a tibial plafond fracture, one had a bimalleolar and a talar fracture, one had a lateral malleolar and a Lisfranc fracture, and one had a calcaneal and a tibial plafond fracture. OATS = osteochondral autograft transplantation system.

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TABLE I A List of the Preoperative Diagnoses

Diagnosis*	No. of Patients
ORIF bimalleolar fracture	15
ORIF lateral malleolar fracture	14
ORIF calcaneal fracture	7
Ankle fusion	6
Calcaneal osteotomy with posterior tibial tendon reconstruction	5
ORIF multiple fractures	4
Bunionectomy	3
ORIF tibial plafond fracture	3
OATS procedure	2
ORIF fifth metatarsal fracture	2
ORIF distal tibial fracture	2
ORIF trimalleolar fracture	1
Distal tibial osteotomy	1
ORIF talar neck fracture	1
Triple arthrodesis	1
Subtalar arthrodesis	1
Talonavicular arthrodesis and calcaneal osteotomy	1

Pain Assessment

The Short-Form McGill Pain Questionnaire (SF-MPQ) was utilized⁸. It demonstrates differences due to treatment, and it includes the present pain intensity scale of the Standard McGill Pain Questionnaire as well a visual analog scale (VAS). The present pain intensity scale uses a categorical scale with integer values between 0 and 5, with 0 indicating “no pain”; 1, “mild”; 2, “discomforting”; 3, “distressing”; 4, “horrible”; and 5, “excruciating.” The VAS has continuous values between 0 and 10.5 cm. The anchors of the VAS are two ticks, one labeled “no pain” and the other labeled “worst possible pain.”

Patients were administered the SF-MPQ at each of two different time points: at the preoperative visit one to seven days before the operation and at six weeks after the operation. For the patient who underwent staged implant removal, the SF-MPQ was administered before and after each procedure. The surveys were filled out by the patient with the assistance of one of the investigators. Also, patients were asked whether they would repeat the procedure if indicated and whether they were satisfied with the results.

Statistical Analysis

A power calculation was performed with use of data from the first thirty patients to determine the sample size required to achieve 0.80 power at the alpha = 0.05 level. The standardized effect size for this initial sample was 1.14, corresponding to a mean difference (and standard deviation) between the preoperative and postoperative VAS scores of 2.2 ± 2.1. Histograms of pain intensities at both time points were created to visualize distributions of pain experienced. Means, standard deviations, and confidence intervals were calculated for the pain reported at both time points. Paired Wilcoxon tests were used to determine whether there was a significant difference between preoperative and postoperative VAS scores or between preoperative and postoperative present pain intensity scores. Wilcoxon test statistics were calculated to determine whether there was a significant difference in postoperative present pain intensity and VAS scores between male and female patients, between ankle and foot hardware, and between patients with and without broken screws. Correlation coefficients were calculated to assess the association between preoperative pain and postoperative pain and between preoperative pain and postoperative pain reduction. Correlation coefficients were also calculated to assess the association between the time between hardware implantation and removal and preoperative pain. Finally, correlation coefficients were calculated to assess the association between age and postoperative pain.

Source of Funding

No funding was received for this study.

Results

Introduction | Materials and Methods | Results | Discussion | References

More patients with high pain levels (a present pain intensity score of 4 or 5) were noted preoperatively than postoperatively. Figure 1 shows the distribution of pain experienced by patients at both time points. Six weeks after the operation, forty-five patients (65%) reported no pain using both the VAS and present pain intensity measures. Compared with the preoperative findings for pain, on both the VAS and present pain intensity measures, postoperatively fifty patients reported less pain, five reported no change, and two reported more pain. Two patients reported less pain on one measure but more pain on the other. Postoperatively, seven patients reported less pain using the VAS measure but no change using the present pain intensity measure, and two patients reported more pain using the VAS measure but pain intensity measure. No patients reported that the pain changed with use of the present pain intensity measure but not the VAS measure. Overall, the VAS and present pain intensity responses were highly correlated, with correlation coefficients of 0.56 before surgery and 0.88 after surgery (p < 0.05 for both; p values were calculated with use of a permutation approach). Of the five patients whose VAS and present pain intensity scores did not change, four had a VAS and present pain intensity score of zero preoperatively because their pain was intermittent and they were not having pain at the time the survey was administered.

Fig. 1

Histograms of reported pain before and after surgery. PPI = present pain intensity score, and VAS = visual analog scale score.

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Table II summarizes the results of the VAS pain measure, and Table III summarizes the results of the present pain intensity measure. By both measures, on average, pain levels were significantly lower postoperatively than preoperatively.

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TABLE II Summary Statistics for the Visual Analog Scale Pain Measure for Sixty-nine Patients (Seventy Ankles)

Time	Mean and Standard Deviation	95% Confidence Interval	P Value
Preoperative	3.06 ± 2.34	2.51, 3.60	<0.05
Postoperative	0.88 ± 1.62	0.50, 1.26

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TABLE II Summary Statistics for the Visual Analog Scale Pain Measure for Sixty-nine Patients (Seventy Ankles)

Time	Mean and Standard Deviation	95% Confidence Interval	P Value
Preoperative	3.06 ± 2.34	2.51, 3.60	<0.05
Postoperative	0.88 ± 1.62	0.50, 1.26

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TABLE III Summary Statistics for the Present Pain Intensity Measure for Sixty-eight Patients (Sixty-nine Ankles)*

Time	Mean and Standard Deviation	95% Confidence Interval	P Value
Preoperative	2.03 ± 1.19	1.75, 2.31	<0.05
Postoperative	0.58 ± 0.98	0.35, 0.81

*Data were not available for one patient.

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TABLE III Summary Statistics for the Present Pain Intensity Measure for Sixty-eight Patients (Sixty-nine Ankles)*

Time	Mean and Standard Deviation	95% Confidence Interval	P Value
Preoperative	2.03 ± 1.19	1.75, 2.31	<0.05
Postoperative	0.58 ± 0.98	0.35, 0.81

*Data were not available for one patient.

With the small sample size in this study, no difference was detected in pain levels between male and female patients, between foot and ankle surgical procedures, or between patients with and without broken screws. Neither patient age nor time between hardware implantation and removal showed an association with pain levels. The correlation coefficients between age and postoperative VAS and present pain intensity scores were 0.05 and 0.09, respectively. Neither was significant. The correlation coefficients between the time from implant placement to removal and preoperative pain were 0.16 (VAS) and 0.02 (present pain intensity). The p value for both was >0.05.

The correlation coefficients between preoperative pain and postoperative pain were 0.24 for the VAS (p < 0.05) and 0.16 for present pain intensity scores (p > 0.05). We also calculated the correlation coefficients between preoperative pain and reduction in pain (i.e., preoperative pain scores minus postoperative pain scores); these were 0.78 for the VAS and 0.73 for present pain intensity (p < 0.05 for both). In other words, patients with higher preoperative pain scores tended to experience higher postoperative pain scores, as well as a greater reduction in pain scores following implant removal.

Of the sixty-eight patients who could be contacted for later follow-up, sixty-four (94%) would repeat the procedure and sixty-two (91%) were satisfied with the results. Three patients would not repeat the procedure, and five patients were not satisfied with the procedure. One patient did not want to participate further in the study. Only two complications were noted, both superficial wound infections, which were successfully treated with local wound care and oral antibiotics.

Discussion

Introduction | Materials and Methods | Results | Discussion | References

Patients who underwent implant removal for symptoms related to foot and ankle implants reported significant amounts of pain reduction postoperatively. The majority of patients felt no pain by six weeks. Furthermore, the majority of patients were satisfied with the procedure and would repeat it if indicated. Our finding that preoperative pain was mildly associated with pain six weeks postoperatively is not surprising. Previously, we found preoperative pain scores to correlate with pain scores six weeks postoperatively in a group of patients undergoing foot and ankle surgery⁹. However, a high preoperative pain score was not associated with poor surgical outcome. In fact, patients with a high score for preoperative pain experienced greater reductions in pain score following the procedure than patients with less pain. Thus, although patients with high preoperative pain scores had higher absolute pain scores postoperatively, they still benefited considerably from the procedure.

There were only two complications, both superficial wound infections. We did not observe any nerve-related complications or refractures. Sanderson et al., in their series of 118 patients undergoing implant removal, observed three cases of nerve injury and one refracture, and Richards et al., in their similar series of eighty-six patients, observed one case of nerve injury and one refracture^7,10. None of these complications involved the foot or ankle. We believe that with careful soft-tissue dissection by an experienced surgeon, nerve injury during implant removal from the foot and ankle is largely avoidable.

A small subset of patients did not experience reduced pain following implant removal. All of the patients in the study had implant-related pain, but some had coexisting diagnoses, such as osteoarthritis. An examination of whether patients with osteoarthritis are as likely to benefit from implant removal as patients without is an avenue for further study.

This study has several limitations. First, although all patients included in the study had pain associated with their implant and elected to undergo the procedure for this reason, five patients had a VAS score and present pain intensity score of zero before surgery because their pain was intermittent and they were not having pain at the time they were surveyed. We did not remove these patients from the study because doing so would have resulted in a biased analysis, making our results appear more significant than they actually are. Second, patients who underwent implant removal were not compared with a separate control group that did not undergo the procedure. We believe this would have yielded little additional benefit, as the procedure was performed only on patients whose symptoms were long-standing and would have been unlikely to change over the duration of the study without intervention. However, it is still not possible to rule out a placebo effect of the surgical procedure. Third, this study only addressed pain, not other implant-associated symptoms, such as reduced joint movement, that can also be alleviated by implant removal. Fourth, although we did not observe a significant association between pain levels and a number of measured variables, including sex, foot surgery compared with ankle surgery, presence of broken screws, age, and time between implantation and removal, it may be that we had insufficient power to detect such associations because of our small sample size. Finally, patients were asked whether they were satisfied with the procedure and would repeat it. These questions have not been validated as an outcome measure and certainly do not reflect the complexity of a patient’s pain experience. However, they have been used in other studies to assess patient satisfaction and the answers were of interest to us^11-13.

Despite these study limitations, our results demonstrate the benefits of implant removal from the patient’s perspective. Foot and ankle implants may be especially bothersome to patients because of the limited amount of soft tissue in the foot and ankle and the demands of weight-bearing activities and shoe wear. To our knowledge, this is the first study to evaluate prospectively the pain experience of patients with regard to the removal of implants from the foot and ankle. Our findings that the majority of patients had no pain by six weeks following implant removal and that they were satisfied with the operation demonstrate that, in most cases, patients with symptoms related to foot and ankle implants find implant removal to be beneficial.

References

Introduction | Materials and Methods | Results | Discussion | References

Rutkow IM. Orthopaedic operations in the United States, 1979 through 1983. J Bone Joint Surg Am. 1986 Jun;68( 5):716-9.[PubMed]

Böstman O; Pihlajamäki H. Routine implant removal after fracture surgery: a potentially reducible consumer of hospital resources in trauma units. J Trauma. 1996 Nov;41( 5):846-9.[CrossRef][PubMed]

Hanson B; van der Werken C; Stengel D. Surgeons’ beliefs and perceptions about removal of orthopaedic implants. BMC Musculoskelet Disord. 2008 May 24;9:73.[CrossRef][PubMed]

Brown OL; Dirschl DR; Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15( 4):271-4.[CrossRef][PubMed]

Jacobsen S; Honnens de Lichtenberg M; Jensen CM; Tørholm C. Removal of internal fixation--the effect on patients’ complaints: a study of 66 cases of removal of internal fixation after malleolar fractures. Foot Ankle Int. 1994 Apr;15( 4):170-1.[PubMed]

Busam ML; Esther RJ; Obremskey WT. Hardware removal: indications and expectations. J Am Acad Orthop Surg. 2006 Feb;14( 2):113-20.[PubMed]

Sanderson PL; Ryan W; Turner PG. Complications of metalwork removal. Injury. 1992;23( 1):29-30.[CrossRef][PubMed]

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30( 2):191-7.[CrossRef][PubMed]

Chou LB; Wagner D; Witten DM; Martinez-Diaz GJ; Brook NS; Toussaint M; Carroll IR. Postoperative pain following foot and ankle surgery: a prospective study. Foot Ankle Int. 2008 Nov;29( 11):1063-8.[CrossRef][PubMed]

Richards RH; Palmer JD; Clarke NM. Observations on removal of metal implants. Injury. 1992;23( 1):25-8.[CrossRef][PubMed]

Gulish HA; Sullivan RJ; Aronow M. Arthroscopic treatment of soft-tissue impingement lesions of the ankle in adolescents. Foot Ankle Int. 2005 Mar;26( 3):204-7.[PubMed]

Carpenter B; Smith J; Motley T; Garrett A. Surgical treatment of hallux rigidus using a metatarsal head resurfacing implant: mid-term follow-up. J Foot Ankle Surg. 2010 Jul-Aug;49( 4):321-5.[CrossRef][PubMed]

Barrack RL; Bertot AJ; Wolfe MW; Waldman DA; Milicic M; Myers L. Patellar resurfacing in total knee arthroplasty. A prospective, randomized, double-blind study with five to seven years of follow-up. J Bone Joint Surg Am. 2001 Sep;83-A( 9):1376-81.[PubMed]

Topics

ankle ; pain ; foot ; implant removal

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Farokh Wadia, Manthravadi Sundar

Posted on August 06, 2012

Too diverse a group of patients

Royal Oldham Hospital, Oldham, Manchester

We read with this article with great interest and would like to congratulate the authors on their hard work. We have following comments to make. We note from Table 1 that the pre-operative diagnosis for these 69 patients comprises quite a heterogeneous group of patients and includes a mix of trauma (49) and elective (20) procedures. We wonder if the authors did any statistical analysis to differentiate the response of patients to hardware removal in these two groups of patients. We feel that these two groups of patients have vastly different pain experiences, as patients who come in for an elective foot and ankle operation (such as ankle or subtalar fusion) have a more complex pain level which may be arising due to involvement of joints adjacent to the ones operated on or from failure of fusion in joints, etc. and may do less well after a hardware removal procedure. It would have been good if the authors had also used a generic quality-of-life score such as SF 36 to determine the general physical and emotional status of their group of patients. Lastly, although the authors note in their discussion that they did not include a control group who had their hardware retained, it would have been interesting to note what proportion of their patients in each diagnostic group underwent hardware removal procedure (e.g. how many ankle fractures were done during the same time period during which 30 patients required hardware removal). This would have added another dimension to the study as to why some hardware becomes symptomatic and some doesn’t.

Kenneth A Egol

Posted on July 30, 2012

Missed reference for this paper

NYU Hospital for Joint Diseases

The authors write that, “…no prospective study in the literature, to our knowledge, has evaluated the patient benefit from implant removal.” I call the authors' attention to “Removal of Painful Orthopaedic Implants after Fracture Union” by Minkowitz et al (1), published in the JBJS, which I co-authored. This was a prospective study evaluating patient benefit following implant removal. The paper was not assigned level 1 evidence because the patients were not followed from time of implantation, only from the time that painful hardware was diagnosed. Our results demonstrated significant benefit from removal of painful implants on outcomes. The current paper demonstrates similar results to the results we had already published and adds to the current understanding of this problem.

REFERENCE: (1) Minkowitz RB, Bhadsavle S, Walsh M, Egol KA. Removal of painful orthopaedic implants after fracture union. J Bone Joint Surg Am. 2007;89(9):1906-12.

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Ariel A. Williams, Daniela M. Witten, Rosanna Duester, Loretta B. Chou; The Benefits of Implant Removal from the Foot and Ankle. The Journal of Bone & Joint Surgery. 2012 Jul;94(14):1316-1320.

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