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Similar clinical and radiographic outcomes after two different hypoallergenic medial unicompartmental knee in patients with metal allergy

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Abstract

Background

The purpose in the present study was to compare clinical and radiological outcomes of patients who had undergone a mobile-bearing unicompartmental knee arthroplasty (UKA) with either titanium niobium nitride (TiNbN) alloy implants or with fixed-bearing oxidized zirconium alloy implants.

Methods

The records of two consecutive cohorts for a total of 86 hypoallergenic implants were prospectively analyzed. The first cohort consisted of 49 consecutive implantations of the hypoallergenic UKA Journey Uni Oxinium (Ox Group), while the second consisted of 37 consecutive series of UKA Oxford (TiNbN Group). All patients were evaluated by two independent surgeons who were not involved in the index surgery. The clinical evaluation consisted of evaluating each patient’s Oxford Knee Score and Knee Society Score day before surgery (T0), and with two consecutive follow-ups at T1 (minimum follow-up 9 months) and T2 (minimum follow-up 24 months).

Results

The two groups were homogeneous in all preoperative values, except Body Mass Index (BMI) and duration of final follow-up [both statistically higher (p < 0.05) in the TiNbN group]. Both groups showed a clinically significant improvement for all scores at final follow-up (p < 0.05). The only differences between the two groups involved a higher pre-operative Oxford Score in TiNbN group (p = 0.031), and different tibial and femoral angles at the final follow-up.

Conclusions

Both TiNbN and Oxinium UKA procedures enabled patients from good to excellent clinical and radiographic outcomes after the final follow-up, regardless of the age, gender, BMI bearing type, and implant size.

Level of evidence: Level II

Comparative study.

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Availability of data and materials

Raw data have been submitted as supplementary material to the Journal.

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Acknowledgements

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Funding

None.

Author information

Authors and Affiliations

Authors

Contributions

All authors contributed equally.

Corresponding author

Correspondence to Riccardo D’Ambrosi.

Ethics declarations

Conflict of interest

The author's declare that they have no competiting interests.

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Permission for the study was obtained from the local ethical committee (a copy of the ethical approval has been submitted).

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Supplementary file1 (XLSX 23 kb)

Appendix 1

Appendix 1

Distribution of femoral, tibial and insert sizes in the two groups.

 

Ox group

n (%)

TiNbN

n (%)

N

49

37

Femoral size

1

2 (4.1)

0 (0.0)

2

9 (18.4)

0 (0.0)

3

18 (36.7)

0 (0.0)

4

16 (32.7)

0 (0.0)

5

4 (8.2)

0 (0.0)

S

0 (0.0)

27 (73.0)

M

0 (0.0)

9 (24.3)

L

0 (0.0)

1 (2.7)

Tibial size

2

7 (14.3)

0 (0.0)

3

16 (32.7)

0 (0.0)

4

11 (22.4)

0 (0.0)

5

14 (28.6)

0 (0.0)

6

1 (2.0)

0 (0.0)

A

0 (0.0)

15 (40.5)

B

0 (0.0)

12 (32.4)

C

0 (0.0)

7 (18.9)

D

0 (0.0)

3 (8.1)

Bearing

3

0 (0.0)

23 (62.2)

4

0 (0.0)

8 (21.6)

5

0 (0.0)

4 (10.8)

6

0 (0.0)

2 (5.4)

8

34 (69.4)

0 (0.0)

9

11 (22.4)

0 (0.0)

10

3 (6.1)

0 (0.0)

11

1 (2.0)

0 (0.0)

Clinical and radiographic results for patients with small femoral size, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbN

Adj p value

N

29

27

  

29

27

Clinical outcomes

OKS

T0

21.41 ± 2.54

23.26 ± 2.73

0.034*

T0T1

 < 0.001*

 < 0.001*

T1

41.31 ± 4.08

42.15 ± 1.32

0.341

T0T2

 < 0.001*

 < 0.001*

T2

44.00 ± 5.38

45.00 ± 1.73

0.758

T1T2

 < 0.001*

 < 0.001*

KSS

T0

51.17 ± 3.54

51.48 ± 5.39

0.804

T0T1

 < 0.001*

 < 0.001*

T1

87.41 ± 5.69

87.70 ± 2.13

0.606

T0T2

 < 0.001*

 < 0.001*

T2

91.52 ± 8.06

91.78 ± 2.93

0.113

T1T2

 < 0.001*

 < 0.001*

Angles at T2

Tibial angle

0.00° ± 3.75

3.11° ± 2.29

0.001*

   

Femoral angle

5.10° ± 2.76

6.81° ± 4.90

0.180

   

Tibial Slope

6.48° ± 1.68

5.26° ± 3.50

0.246

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

Clinical and radiographic results for patients with big femoral size, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbN

Adj p value

N

20

10

  

20

10

Clinical outcomes

OKS

T0

22.00 ± 2.38

22.50 ± 2.72

0.549

T0T1

 < 0.001*

0.017*

T1

41.20 ± 3.04

41.90 ± 2.64

0.790

T0T2

 < 0.001*

0.006*

T2

44.85 ± 2.81

45.20 ± 2.35

0.929

T1T2

0.001*

0.196

KSS

T0

51.10 ± 4.13

51.50 ± 4.20

0.858

T0T1

 < 0.001*

0.018*

T1

86.75 ± 4.69

87.50 ± 2.37

0.499

T0T2

 < 0.001*

0.018*

T2

92.20 ± 4.54

92.30 ± 4.55

0.493

T1T2

 < 0.001*

0.017*

Angles at T2

Tibial angle

0.05° ± 3.61

2.90° ± 1.66

0.010*

   

Femoral angle

4.05° ± 3.19

7.40° ± 3.44

0.013*

   

Tibial Slope

4.70° ± 3.57

4.80° ± 2.30

0.876

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

Clinical and radiographic results for patients with small tibial size, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbn

Adj p value

N

23

15

  

23

15

Clinical outcomes

OKS

T0

21.52 ± 2.52

23.07 ± 2.15

0.050

T0T1

 < 0.001*

0.002*

T1

41.52 ± 4.32

42.80 ± 1.61

0.178

T0T2

 < 0.001*

0.002*

T2

43.96 ± 5.98

44.67 ± 1.84

0.704

T1T2

0.005*

0.041*

KSS

T0

51.26 ± 3.62

51.53 ± 5.45

0.834

T0T1

 < 0.001*

0.002*

T1

87.74 ± 6.32

87.73 ± 1.91

0.180

T0T2

 < 0.001*

0.002*

T2

91.39 ± 9.02

91.73 ± 3.01

0.134

T1T2

0.002*

0.004*

Angles at T2

Tibial angle

−0.26° ± 3.85

3.73° ± 2.43

0.001*

   

Femoral angle

4.65° ± 2.69

5.40° ± 5.53

0.905

   

Tibial Slope

5.87° ± 2.01

6.47° ± 2.85

0.565

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score; KSS Knee Society Score.

Clinical and radiographic results for patients with large tibial size, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbN

Adj p value

N

26

22

  

26

22

Clinical outcomes

OKS

T0

21.77 ± 2.47

23.05 ± 3.08

0.255

T0T1

 < 0.001*

 < 0.001*

T1

41.04 ± 3.03

41.59 ± 1.68

0.785

T0T2

 < 0.001*

 < 0.001*

T2

44.69 ± 2.65

45.32 ± 1.91

0.614

T1T2

 < 0.001*

0.001*

KSS

T0

51.04 ± 3.92

51.45 ± 4.88

0.933

T0T1

 < 0.001*

 < 0.001*

T1

86.62 ± 4.18

87.59 ± 2.36

0.152

T0T2

 < 0.001*

 < 0.001*

T2

92.15 ± 4.09

92.05 ± 3.67

0.328

T1T2

 < 0.001*

 < 0.001*

Angles at T2

Tibial angle

0.27° ± 3.53

2.59° ± 1.79

0.007*

   

Femoral angle

4.69° ± 3.22

8.05° ± 3.40

0.002*

   

Tibial Slope

5.65° ± 3.29

4.23° ± 3.16

0.182

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

Clinical and radiographic results for patients with small bearing, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbN

Adj p value

N

34

23

  

34

23

Clinical outcomes

OKS

T0

21.35 ± 2.58

22.57 ± 2.69

0.101

T0T1

 < 0.001*

 < 0.001*

T1

41.15 ± 4.34

42.26 ± 2.03

0.367

T0T2

 < 0.001*

 < 0.001*

T2

43.91 ± 5.31

45.00 ± 1.81

0.811

T1T2

 < 0.001*

0.004*

KSS

T0

50.91 ± 3.62

52.13 ± 5.18

0.481

T0T1

 < 0.001*

 < 0.001*

T1

87.09 ± 6.24

88.04 ± 1.97

0.805

T0T2

 < 0.001*

 < 0.001*

T2

91.62 ± 8.06

92.35 ± 3.64

0.265

T1T2

 < 0.001*

 < 0.001*

Angles at T2

Tibial angle

0.38° ± 3.52

3.30° ± 2.36

0.001*

   

Femoral angle

4.53° ± 2.81

6.87° ± 4.81

0.052

   

Tibial Slope

5.71° ± 3.02

5.57° ± 2.94

0.737

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

Clinical and radiographic results for patients with large bearing, in Ox and TiNbN group, respectively, at T0, T1 and T2.

 

Groups

Between group comparison

p value

Within group time comparison

Ox group

Mean ± SD

TiNbN

Mean ± SD

 

Ox group

Adj p value

TiNbN

Adj p value

N

15

14

  

15

14

Clinical outcomes

OKS

T0

22.33 ± 2.13

23.86 ± 2.63

0.233

T0T1

0.002*

0.003*

T1

41.53 ± 1.13

41.79 ± 1.12

0.628

T0T2

0.002*

0.003*

T2

45.33 ± 1.11

45.14 ± 2.07

0.876

T1T2

0.002*

0.007*

KSS

T0

51.67 ± 4.10

50.43 ± 4.80

0.227

T0T1

0.002*

0.003*

T1

87.27 ± 1.79

87.00 ± 2.39

0.787

T0T2

0.002*

0.003*

T2

92.20 ± 2.18

91.21 ± 2.89

0.198

T1T2

0.002*

0.005*

Angles at T2

Tibial angle

−0.80° ± 3.95

2.64° ± 1.65

0.020*

   

Femoral angle

5.00° ± 3.34

7.14° ± 4.15

0.155

   

Tibial Slope

5.87° ± 2.03

4.43° ± 3.59

0.310

   

SD Standard deviation; * = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

Statistical significant correlations between clinical score and angles.

 

Ox group

N = 49

Rho (p value)

TiNbN

N = 37

Rho (p value)

Physical activity indexes

OKS

 

T0

T1

T0

T1

T1

0.17 (0.252)

1.00

0.07 (0.663)

1.00

T2

0.11 (0.449)

0.77 (< 0.001*)

−0.36 (0.028*)

−0.28 (0.091)

KSS

 

T0

T1

T0

T1

T1

0.05 (0.711)

1.00

0.22 (0.182)

1.00

T2

0.02 (0.902)

0.59 (< 0.001*)

0.41 (0.013*)

0.45 (0.005*)

Angles at T2

 

Tibial Slope

Tibial angle

Tibial Slope

Tibial angle

Tibial angle

0.18 (0.205)

1.00

−0.07 (0.678)

1.00

Femoral angle

0.18 (0.210)

0.36 (0.011*)

−0.29 (0.081)

0.07 (0.698)

Significant correlations between clinical outcomes, angles and other continuous variables.

Ox group

N = 49

TiNbN

N = 37

Variables

Rho (p value)

Variables

Rho (p value)

OKS T0

KSS T0

0.39 (0.006*)

OKS T2

KSS T1

0.33 (0.044)

OKS T2

KSS T0

0.31 (0.031*)

KSS T0

Weight

0.44 (0.007*)

OKS T1

KSS T1

0.57 (< 0.001*)

KSS T2

Weight

0.36 (0.029*)

OKS T2

KSS T1

0.57 (< 0.001*)

Femoral angle

Final follow−up

0.36 (0.029*)

OKS T1

KSS T2

0.48 (< 0.001*)

   

OKS T2

KSS T2

0.45 (< 0.001*)

   

KSS T2

Age

−0.34 (0.016*)

   

Femoral angle

Final follow-up

0.39 (0.006*)

   

* = statistical significant value (p < 0.05).

OKS Oxford Knee Score, KSS Knee Society Score.

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D’Ambrosi, R., Ursino, N., Mariani, I. et al. Similar clinical and radiographic outcomes after two different hypoallergenic medial unicompartmental knee in patients with metal allergy. Eur J Orthop Surg Traumatol 33, 1315–1328 (2023). https://doi.org/10.1007/s00590-022-03295-y

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  • DOI: https://doi.org/10.1007/s00590-022-03295-y

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