Journal of Orthopaedics and Traumatology

Official Journal of the Italian Society of Orthopaedics and Traumatology

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Open Access

Nicotine consumption may lead to aseptic loosening in proximal mega-prosthetic femoral replacement

  • Philip J. F. Leute1Email author,
  • Isabel Hoffmann1,
  • Ahmed Hammad1,
  • Stefan Lakemeier1,
  • Hans-Michael Klinger1 and
  • Mike H. Baums1, 2
Journal of Orthopaedics and TraumatologyOfficial Journal of the Italian Society of Orthopaedics and Traumatology201618:426

https://doi.org/10.1007/s10195-016-0426-7

Received: 12 November 2015

Accepted: 2 August 2016

Published: 17 August 2016

Abstract

Background

Aseptic loosening after total hip arthroplasty is likely related to nicotine ingestion. However, aseptic loosening as a direct consequence of smoking habits has not been described with regard to proximal mega-prosthetic femoral replacement. The aim of the present study was to evaluate the association between nicotine consumption and aseptic loosening rates after proximal mega-prosthetic femoral replacement.

Materials and methods

A consecutive series of patients who received mega-prosthetic replacement of the proximal femur at our hospital between 2005 and 2015 were included. Their files were reviewed and evaluated for the influence of smoking on aseptic loosening rates. All living patients were invited to complete a functional follow-up assessment at our clinic.

Results

Twenty-six patients with 27 prostheses were included. Five patients were active smokers, and 21 patients were non-smokers. Aseptic loosening was observed in three patients in the smoking group, whereas none of the non-smokers developed aseptic loosening. Fisher’s exact test showed a relationship between nicotine consumption and aseptic loosening of the prostheses (p = 0.003).

Conclusions

Smoking increases the likelihood of aseptic loosening after proximal mega-prosthetic femoral replacement.

Level of evidence

Level 4 according to Oxford Centre of Evidence-Based Medicine 2011.

Keywords

Smoking Nicotine Complication Femur Proximal Replacement Aseptic Loosening

Introduction

Mega-prosthetic replacement of the proximal femur has become a standard procedure to treat primary bone tumors, metastases and large bone defects after orthopedic surgeries using a large, special type of total hip arthroplasty (Fig. 1). The orthopedic surgeon must understand the reasons for postoperative complications to avoid them and ensure that the patient has a high-quality postoperative outcome. Although various complications occur after the implantation of these prostheses, aseptic loosening rates are of particular interest because they are notably higher than after standard total hip arthroplasty (5–27 %) [13]. A large meta-analysis recently demonstrated that nicotine consumption was associated with higher aseptic loosening rates after standard total hip arthroplasty [4]. However, smoking has not been established as a risk factor for aseptic loosening after mega-prosthetic proximal femoral replacement. Considering the aforementioned recent study results regarding standard total hip arthroplasty, we hypothesized that smoking habits also influence the aseptic loosening rates of mega-prosthetic proximal femoral replacement. Therefore, this study sought to test the correlation between the aseptic loosening of these prostheses and nicotine consumption.
Fig. 1

Proximal femur replacement

Materials and methods

Protocol

In accordance with our unpublished study protocol ‘Nicotine consumption and proximal femoral replacement: a 10-year single-center analysis’, the present study was designed as a retrospective, single-center study with a one-time cross-sectional functional follow-up assessment for all surviving patients. We planned to include at least 20 patients with seven different surgeons in this study. To support our hypothesis, the patients would be segregated into smoking and non-smoking groups, and the aseptic loosening rates would be compared between groups. Smokers were defined as patients who had consumed nicotine before and after implantation of the femoral mega-prosthesis, whereas all other patients were defined as non-smokers. Aseptic loosening was defined based on pain upon ambulation and radiological evidence of periprosthetic bone resorption without signs of infection (via culture-positive swabs or blood samples). Radiological evidence of periprosthetic bone resorption was obtained using standardized X-rays (antero-posterior and Lauenstein’s oblique lateral projection) that were independently evaluated by a radiologist and an orthopedic surgeon. A microbiologist analyzed intraoperatively obtained swabs that were considered positive when the same bacteria were present in two of five swabs or when the patient had additional signs of bacteremia (elevated C-reactive protein [CRP] levels or leukocytosis).

Statistical analyses

The differences in aseptic loosening rates between the groups of smokers and non-smokers were analyzed using Fisher’s two-tailed exact test because it is reliable for small sample sizes. In addition, a Kaplan–Meier analysis was used to evaluate the patient and prosthesis survival rates. The means, standard deviations (SDs), medians and ranges were calculated for all data. All statistics were computed using StatSoft, Inc. (2014) STATISTICA data analysis software (StatSoft, Inc., Tulsa, OK, USA), version 12.0.

Methodological approach

To obtain our study group, we requested information from the controlling department of our hospital, where all diagnoses and procedures are matched to the treated patients and retained. All potential cases of proximal mega-prosthetic femoral replacement between 2005 and 2015 were identified according to the International Classification of Procedures in Medicine (ICPM) figures that were used to code operations involving femoral replacement with special prostheses (confer Supplementary Material). All patient files and X-rays were reviewed, and all patients who received special femur prostheses other than a proximal femoral replacement were excluded. Only cases in which the surgical procedure was comparable with that used for these implants were included (i.e., transection of the proximal femur in the subtrochanteric region and replacement of the proximal part using an implant with a large monopolar femoral head and a cone for intramedullary insertion into the femur). Only those cases in which the implants were cemented and not attached to the bone with additional screws or plates were included.

Patient baseline characteristics

Baseline data including sex, age and preoperative data regarding body mass index (BMI), American Society of Anesthesiologists (ASA) physical status [5], number and type of concomitant diseases, number and type of medications, alcohol consumption and use of illicit drugs were documented based on the available patient files. The surgical protocols were reviewed, and the data regarding the implant manufacturer, operating surgeon, cementation, implants at the surgical site prior to implantation, intraoperative complications and duration of surgery were recorded. The postoperative period was investigated, and data were recorded regarding the application, type and amount of postoperative antibiotics, duration of bed rest, duration of days until fully weight bearing, rehabilitation after inpatient treatment, postoperative chemotherapy or radiation, duration of inpatient treatment and postoperative complications.

Nicotine consumption and aseptic loosening

Next, the data regarding nicotine consumption prior to surgery were recorded. Smoking habits (i.e., amount and duration in cigarette pack years [py], consumption of tobacco via cigar, pipe or snuff tobacco) prior to surgery were documented based on patient files because the ward nurses routinely record this information for every patient upon admission. To determine postoperative nicotine consumption, the patients (or their living relatives when the patients were deceased) were contacted and interviewed about their smoking habits after proximal femur replacement.

All of the documentation from the patient follow-up assessments and subsequent operations with the attendant X-rays were then reviewed to determine how many patients from each group developed aseptic loosening.

Functional follow-up assessment

All living patients were invited to complete a functional follow-up assessment at our clinic. These evaluations were performed using the harris hip score (HHS) [6], toronto extremity salvage score (TESS) [7], musculoskeletal tumor society score (MSTS) [8] and short form 36 (SF36) [9]. Moreover, leg length was recorded for every patient and compared with the documentation in their files or measured at the functional follow-up assessment.

Results

Methodological approach

A total of 225 cases of special femoral prostheses implantation were identified. All of the patient files and X-rays were reviewed, resulting in the exclusion of 198 patients who had not received a proximal femoral replacement but a different femoral prosthesis or had undergone a surgical procedure that differed from the study protocol.

Patient baseline characteristics

Twenty-six patients who received proximal femoral replacements were included in this study. Fourteen women and 12 men received 27 prostheses, including one patient who received bilateral prostheses. All protheses stems were cemented with gentamicin-loaded polymethylmethacrylate bone cement. The indications were metastatic bone disease in 16 cases, malignant primary bone tumors in six cases, bone loss after orthopedic surgery in four cases and a benign bone tumor in one case (Table 1).
Table 1

Patient baseline characteristics and complications

Patient

Gender

Age

DM

RA

Nicotine

Reason for replacement

Implant at hip prior to operation

Manufacturer

1

M

76.0

NS

Metastasis urothel-carcinoma

Cremascoli

2

M

66.8

S (49 py)

Malignant histiocytoma

Cremascoli

3

F

66.9

NS

Metastasis mamma-carcinoma

Implantcast

4

F

75.4

NS

Metastasis mamma-carcinoma

LINK

5

F

62.3

Yes

NS

Metastasis mamma-carcinoma

Implantcast

6

M

73.6

NS

Plasmocytoma

Standard hip endoprosthesis

Implantcast

7

F

66.9

Yes

NS

Plasmocytoma

Implantcast

8

M

73.3

S (52 py)

Metastatic adenocarcinoma prostate

Implantcast

9

M

37.6

S (20 py)

Chondrosarcoma

Implantcast

10 left leg

F

60.0

NS

Metastasis mamma-carcinoma

Intramedullary femur nail

Implantcast

10 right leg

F

59.8

NS

Metastasis mamma-carcinoma

Intramedullary femur nail

Implantcast

11

M

55.4

S (36 py)

Fibrous dysplasia, pathological fracture

Implantcast

12

F

56.6

NS

Metastasis mamma-carcinoma

Intramedullary femur nail

Eska Implants

13

M

56.2

NS

Metastatic renal cell carcinoma

Eska implants

14

F

77.5

Yes

Yes

NS

Bone loss after osteosynthesis

Intramedullary femur nail

Eska implants

15

F

66.4

NS

Metastatic renal cell carcinoma

Metal plate

Eska implants

16

M

52.9

NS

Metastatic renal cell carcinoma

Eska implants

17

F

75.7

NS

Metastatic renal cell carcinoma

Eska implants

18

M

81.7

S (67 py)

Bone loss after removal of hip prosthesis

Standard hip endoprosthesis

Eska Implants

19

M

59.7

NS

Chondrosarcoma

Standard hip endoprosthesis

Implantcast

20

F

74.0

NS

Plasmocytoma

Intramedullary femur nail

Eska implants

21

F

66.6

NS

Metastasis mamma-carcinoma

Intramedullary femur nail

Eska implants

22

F

72.8

NS

Bone loss after removal of hip prosthesis

Standard hip and knee endoprosthesis

Eska implants

23

M

70.4

NS

Metastatic renal cell carcinoma

Orthodynamics

24

F

57.6

NS

Bone loss after osteosynthesis

Intramedullary femur nail

Orthodynamics

25

M

77.1

Yes

Yes

NS

Metastasis bronchial adenocarcinoma

Orthodynamics

26

F

60.9

NS

Metastasis mamma-carcinoma

Orthodynamics

Patient

Duration of

operation

(min)

Intra-/postoperative complications

Time primary operation-first following operation

Reasons for all implant related following operations

Amount of following related operations

Time to removal of implant

(months)

Situation after implant removal

Time from implantation yo death or alive

1

267

–/Wound infection, lymphatic edema

10.2 months

Superficial infection (enterococcus faecalis, staphylococcus epidermidis)

1

  

0.9 years

2

 

–/Hematoma, dislocation <3 months after surgery

1 day

Hematoma, dislocation

2

  

1.0 years

3

158

–/–

     

0.4 years

4

146

–/–

     

0.6 years

5

143

–/–

     

3.0 years

6

260

–/Dislocation >3 months after surgery

     

1.3 years

7

108

–/–

     

1.7 years

8

155

–/–

     

0.1 years

9

300

–/Aseptic shaft loosening

71.0 months

Aseptic shaft loosening

1

71.0

Re-implantated proximal cemented femoral replacement

Alive

10 left leg

 

–/Dislocation >3 months after surgery

     

3.3 years

10 right leg

 

–/–

     

3.5 years

11

229

–/Aseptic shaft loosening

12.0 months

Aseptic shaft loosening

1

12.0

Re-implantated proximal cemented femoral replacement

Alive

12

273

–/Wound infection, urinary tract infection

6.0 months

Superficial infection (staphylococcus epidermidis, corynebacterium species)

4

  

0.8 years

13

242

–/Wound infection

5.2 months

Superficial infection (staphylococcus aureus)

1

  

0.5 years

14

306

–/Sigma diverticulitis

     

0.7 years

15

201

–/Wound healing deficiency without infection

4.2 months

Wound healing deficiency without infection

1

  

0.9 years

16

269

–/Dislocation <3 months after surgery

2.4 months

Dislocation

1

  

5.3 years

17

219

–/–

     

Alive

18

341

Femoral vein lesion / aseptic shaft loosening

45.5 months

Aseptic shaft loosening

1

45.5

Total femoral replacement

Alive

19

 

–/Gluteal insufficiency, local tumor recurrence

82.9 months

Local tumor recurrence

1

82.9

Hip ex-articulation without implant

Alive

20

240

–/Dislocation >3 months after surgery, recurrent

43.3 months

Dislocation

1

  

Alive

21

244

–/Wound infection, hematoma, urinary tract infection

0.4 months

Superficial infection (staphylococcus haemolyticus), hematoma

2

  

0.7 years

22

295

–/Wound infection

12.5 months

Deep infection/septic loosening (MRSA, MRSE, staphylococcus capitis, campylobacter fetus)

5

13.9

Girdlestone situation with attendant femoral amputation

Alive

23

240

–/Dislocation >3 months after surgery

     

Alive

24

220

–/–

     

Alive

25

183

–/Dislocation >3 months after surgery

     

0.4 years

26

224

–/–

     

Alive

M male, F female, NS non-smoker, S smoker, DM diabetes mellitus, RA rheumatoid arthritis, Py pack years of nicotine consumption, MRSA methicillin-resistant staphylococcus aureus, MRSE methicillin-resistant staphylococcus epidermidis

The average age at surgery was 65.9 years (SD ± 9.9, median 66.8, range 37.6–81.7) with an average BMI of 27.4 (SD ± 5.6, median 26.0, range 16.4–41.1). The patients had 4.4 concomitant diseases on average (SD ± 2.1, median 5.0, range 1.0–7.0) and were prescribed 5.4 medications on average (SD ± 3.5, median 5.0, range 1.0–14.0). The average ASA score at surgery was 2.5 (SD ± 0.6, median 3.0, range 1.0–3.0).

The average duration of surgery was 228.8 min (SD ± 59.2, median 240.0, range 108.0–341.0). Only one of 27 surgeries produced an intraoperative complication (femoral vein lesion). This lesion was sutured immediately and healed without further incident. During the postoperative period, the average duration of bed rest was 6.3 days (SD ± 4.4, median 7.0, range 0.0–14.0), and the average number of days until patients were fully weight bearing was 27.4 (SD ± 23.8, median 16.5, range 0.0–100.0). Twenty-three of 27 patients received postoperative antibiotics (18 received cefuroxime; five received cefuroxime and clindamycin) for an average of 26 days (SD ± 33.7, median 10.0, range 3.0–90.0). Inpatient treatment lasted 31.0 days on average (SD ± 16.5, median 27.0, range 8.0–94.0). Sixteen of 27 patients underwent postoperative rehabilitation. The application of postoperative chemotherapy was documented for 7 of 27 patients, and postoperative radiation was documented for 9 of 27 patients. Three of our patients regularly consumed alcohol, but none of these patients used illicit drugs.

Nicotine consumption and aseptic loosening

Five patients were smokers, whereas 21 patients were non-smokers. The smokers consumed nicotine via cigarettes prior to implantation for an average of 44.8 py (SD ± 17.7, median 49, range 20–67). None of the patients ingested tobacco via cigar, pipe or snuffing. After an average follow-up period of 2.7 years (SD ± 2.3, median 1.7, range 0.1–7.9), the X-rays revealed signs of bone resorption in four of 27 prostheses (Fig. 2).
Fig. 2

Aseptic loosening

One of these patients showed microbiological testing results indicating infection with methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant S. epidermidis (MRSE) with leukocytosis and elevated CRP levels. Thus, this patient was classified as having septic loosening. This patient underwent a girdlestone procedure with additional above-knee amputation due to concomitant infection of the adjacent knee prosthesis.

The remaining three patients did not show bacterial growth according to microbiological tests and did not have signs of infection in their blood; hence, they were classified as having aseptic loosening. Throughout the course of the follow-up assessments of two of these patients, the proximal femoral replacement was exchanged for a similar proximal mega-prosthesis, whereas the third patient received a total femoral replacement. All three of these patients were smokers, whereas none of the non-smokers developed aseptic loosening. Fisher’s two-tailed exact test revealed a significant relationship between nicotine consumption (smoking) and aseptic loosening (p = 0.003).

Functional follow-up assessment

Ten of 26 patients were alive at the time of this study, with eight of 27 prostheses remaining; all of these patients were available for a functional follow-up assessment (Table 2). No patient death (16/26) was related to the implantation of the mega-prosthesis or to any subsequent complication. The average age at the follow-up assessment was 69.2 years (SD ± 12.5; median 70.9; range 44.6–86.7). The time from primary implantation to the follow-up assessment was 4.7 years on average (SD ± 2.2; median 4.8; range 0.8–7.9). Of the 10 survivors, five had the original implant; however, the implant was removed from the hips of the other five patients. The average time between implantation and removal was 45.1 months (SD ± 32.3; median 45.5; range 12.0–82.9). Apart from the aforementioned three cases of aseptic loosening and one case of septic loosening, one patient underwent hip ex-articulation because of local tumor recurrence (chondrosarcoma). Another patient was wheelchair-bound due to Parkinson’s disease and multiple osteoporotic spinal fractures. A Kaplan–Meier analysis revealed that the prosthesis survival rates were generally higher than the patient survival rates (Fig. 3).
Table 2

Functional follow-up

Patient

Age at follow-up (years)

Time from implantation until functional follow-up (years)

Hip situation at follow-up

Knee society score (%)

Harris hip score (%)

Toronto extremity salvage score (%)

Musculoskeletal tumor society score (%)

Musculoskeletal tumor society score (points out of 30)

Short form 36 physical functioning

9

44.6

7.1

Proximal cemented femoral replacement

  

73.6

50

15

30

11

61.8

6.4

Proximal cemented femoral replacement—wheelchair bound due to Parkinson’s disease and osteoporotic spinal fractures

  

34

10

3

20

17

80.7

5.0

Proximal cemented femoral replacement

 

90

85

93.3

28

100

18

86.7

5.0

Total femoral replacement

83

65

57

50

15

25

19

67.6

7.9

Hip ex-articulation

  

76

40

12

35

20

78.6

4.6

Proximal cemented femoral replacement

 

51

52.8

33.3

10

15

22

76.8

4.0

Girdlestone situation with femur amputation

  

48.3

63.3

19

10

23

74.2

3.8

Proximal cemented femoral replacement

 

72

64.3

56.7

17

25

24

59.6

2.0

Proximal cemented femoral replacement

 

94

91.1

96.7

29

75

26

61.7

0.8

Proximal cemented femoral replacement

 

93

68

80

24

50

Patient

Short form 36 role-physical

Short form 36 bodily pain

Short form 36 general health

Short form 36 vitality

Short form 36 social functioning

Short form 36 role-emotional

Short form 36 mental health

Short form 36 physical component summary measure

Short form 36 mental component summary measure

9

100

84

20

30

25

33.3

44

42.9

29.7

11

0

10

20

30

12.5

0

24

25.1

26.1

17

100

100

67

95

100

100

100

53.7

61.8

18

100

84

52

55

87.5

100

68

39.2

55.5

19

0

62

77

75

87.5

100

72

30.6

62.2

20

0

41

20

50

100

0

52

24.9

45.7

22

0

41

67

50

75

0

52

29.9

42.8

23

50

64

57

55

100

100

96

28.5

67.2

24

75

100

25

55

100

100

44

47.6

46

26

0

100

40

20

100

0

40

42.9

32.9

Fig. 3

Kaplan−Meier analysis

The six patients with proximal femoral replacements who had the ability to walk had an average TESS of 72.5 % (SD ± 14.0; median 70.8; range 52.8–91.1), an average MSTS of 68.3 % (SD ± 25.5; median 68.4; range 33.3–96.7), and an average SF36 physical component summary score of 40.1 points (SD ± 11.2; median 42.9; range 24.9–53.7), whereas the average SF36 mental component summary score was 47.2 points (SD ± 15.0; median 45.9; range 29.7–67.2). The HHS of all patients with a functioning hip mega-prosthesis was 77.5 % on average (SD ± 17.7; median 81.0; range 51.0–94.0). The leg length measurement based on patient files or the functional follow-up assessment showed an average difference of −0.3 (±0.9 SD) cm (median 0.0; range −1.5 to 1.0) between the prosthesis leg and the healthy contralateral side.

Discussion

Aseptic loosening and nicotine consumption

The principal result of this study revealed that smoking is related to aseptic loosening in the mega-prosthetic replacement of the proximal femur. Thus, our hypothesis was valid for the present sample.

The aseptic loosening rate observed in this study (3/27) was comparable with the rates published in literature ranging from 5−27 % [13]. No other studies have identified smoking as a risk factor for aseptic loosening after the mega-prosthetic replacement of the proximal femur. However, the effects of smoking regarding the rates of aseptic loosening for other hip implants and bone healing are controversial. Some studies have not found a correlation between smoking and aseptic loosening after total hip arthroplasty [10, 11], whereas other studies have shown a correlation between smoking and aseptic loosening after total hip arthroplasty [12] as well as between smoking and revision total hip arthroplasty [13]. The latter observation is supported by our data.

Biochemically, several clues indicate how nicotine slows bone healing. Nicotine, through the activation of the cholinergic anti-inflammatory pathway, might partially and indirectly slow bone healing by inhibiting tumor necrosis factor-α (TNF-α) secretion [14]. TNF-α appears to be part of a cascade that leads to the expression of crucial proteolytic enzymes (matrix metalloproteinases 9, 13 and 14), which are necessary in fracture healing to progress from the soft callus stage to endochondral ossification [4, 15, 16]. Thus, the bone remains soft for a prolonged period in their absence. Delayed bone healing after the implantation of a proximal mega-prosthetic femoral replacement is extremely problematic because the femur and the implanted prosthesis must bear the patient’s full bodyweight during normal ambulation and stair climbing. During normal ambulation, this force can be 2.3 times the patient’s bodyweight [17]. Presumably, this delayed bone healing causes the unwanted prolonged motion of the implant within the bone and hinders proper osseointegration, thereby leading to aseptic loosening, even when the prosthesis is cemented.

In conclusion, smokers require special counseling before and after implantation of a mega-prosthetic replacement of the proximal femur to cease or at least reduce their smoking habits. They must be informed about their increased risk for aseptic loosening.

Functional follow-up assessment: patient and prosthesis survival

The recent follow-up assessment revealed satisfactory results for all of the patients who survived with a functional hip prosthesis. This finding corroborates the current literature, which shows that successful functional results can be achieved for most patients after implantation of a mega-prosthetic replacement of the proximal femur [18, 19]. The Kaplan–Meier analysis showed that the cumulative survival of the prostheses was generally longer than the cumulative survival of the patients. In fact, the low patient survival rates were because of metastatic tumor diseases, which are the most common reasons for the implantation of these prostheses. After 7 years, we observed that prosthesis survival fell below patient survival. However, censoring of patients explains this change. Time will reveal how long the survivors will live with their prostheses and whether this effect will remain after additional years of observation.

Limitations

One limitation of this study was clearly its small sample size. Because we included all of our patients with these types of prostheses over the past 10 years in this study, we were unable to increase our sample size. Although seven orthopedic surgeons performed this operation over the past decade, the surgical procedure, according to the study design, was the same for all of the patients and therefore provided comparable results. Apart from smoking, we were unable to identify any other factor that influenced aseptic loosening. Therefore, matching the smokers with comparable non-smokers based on sex, age, BMI, indication for operation, duration of operation, chemotherapy, radiation and implant at the surgical site prior to implantation would not have changed the results. However, we concede that matching was not possible because of the lack of appropriate matching partners. In addition, heterogeneous indications for implantation (malignant vs benign) and comorbidities led to strong differences regarding the survival rates of the patients.

Declarations

Acknowledgments

We thank Mr. Rouven Haschka and Ms. Xenia Schulz of the Biometrics Department at the University of Göttingen for their support in analyzing the data.

Compliance with ethical standards

Ethical standards

All patients gave the informed consent prior being included into the study. All procedures involving human participants were in accordance with the 1964 Helsinki declaration and its later amendments. The study was approved by the Research Ethics Committee.

Conflict of interest

The authors declare that they have no conflict of interest.

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Authors’ Affiliations

(1)
Department of Orthopedic Surgery, University of Göttingen
(2)
Department of Orthopedic Surgery, Helios Aukammklinik

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