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International Orthopaedics

, Volume 42, Issue 7, pp 1535–1544 | Cite as

Real-time computerised tomography assisted porous tantalum implant in ARCO stage I-II non-traumatic osteonecrosis of the femoral head: minimum five-year follow up

  • Ruyin Hu
  • Pengfei Lei
  • Bo Li
  • Hao Liu
  • Xucheng Yang
  • Ting Wen
  • Yihe Hu
  • Xiaobin Tian
Original Paper

Abstract

Purposes

This study was established to investigate the medium-term clinical effect of real-time CT assisted porous tantalum implant for the treatment of ARCO stage I-II non-traumatic osteonecrosis of the femoral head (ONFH).

Methods

This study comprised 24 ONFH patients (29 hips) who were treated with intra-operative real-time CT accurate rapid positioning assisted drilling decompression, lesion removal and porous tantalum implant. Harris score, VAS score and imaging in pre-operation and follow-up period were recorded.

Results

The average operative time and intra-operative blood loss were 72.6 min and 158.8 ml, respectively. The mean follow-up was 5.4 years. No femoral head penetrating, wound infection, and death occurred. Harris and VAS score improved significantly (73.78 vs. 88.11; 7.13 vs. 2.66) at last follow-up (P < 0.05). The functional improvement and pain relief rate was 100% at six months after operation. The effective rate was 86.21% at 12 months after operation and last follow-up. Five pre-operative ARCO stage I hips had no radiographic progress. Meanwhile, four among the 24 ARCO stage II hips progressed into stage III between eight and 12 months after surgery, among which two progressed into stage IV and two remained in stage III at the last follow-up. The average value of Kerboul combined necrotic angle was 263.24°. There was no progress in Kerboul combined necrotic angle among the grades 2 and 3 patients. However, among the six cases at grade 4, four cases with post-operative progress, two patients converted to THA.

Conclusions

Our technique is safety and effective in the treatment of ARCO stage I-II non-traumatic ONFH.

Keywords

Real-time CT accurate positioning Porous tantalum implant Osteonecrosis of the femoral head 

Introduction

ONFH is a disease in which bone death occurs as a result of impairment of blood supply to the femoral head [1, 2]. The patient presented with pain and dysfunction in the hip joint and progressive limp [3]. Debilitated blood supply to the femoral head commonly leads to necrosis and collapse of the femoral head [4]. In spite of various research efforts and trials, ONFH is still one of the most serious orthopaedic problems. More than 500,000 hip replacements were performed for ONFH patients annually in the USA [5]. Many therapies have been applied to animal models and patients to prevent the progress of ONFH. Nonsurgical therapies include anti-osteoporosis medicine, anticoagulants, lipid-lowering medicine, electromagnetic stimulation, shockwave therapy, and hyperbaric oxygen therapy, while surgical therapies consist of autologous bone marrow stem cell transplantation, core decompression and total hip replacement [6, 7].

Porous tantalum is a biomaterial with a unique set of physical and mechanical properties. It has a high-volume porosity (> 80%) with fully interconnected pores to allow secure and rapid bone ingrowth [8]. In addition, it has a modulus of elasticity similar to that of bone, which minimizes stress-shielding. The material is structural and has sufficient strength to allow physiological load-carrying capabilities in the manufactured implant [9]. Porous tantalum implant is a minimally invasive and hip preserving method, which has been widely applied to patients with early-stage ONFH [10]. It has more advantages than pure core decompression and free vascularized fibula transplant [11, 12]. There are many clinical studies on porous tantalum implant for the treatment of ONFH, but its clinical effect varies. The success rate of early-stage non-traumatic ONFH surgery was 67.7 to 86% [12, 13, 14, 15]. In contrast to previous encouraging studies, one study showed only 64.29% satisfactory results at one year follow-up, the conversion to THA occurred after a mean time of 305 days (0.84 years). The reasons for high failure rates may be related to patient selection, improper implantation position, failure to remove necrotic lesions and improper implantation of tantalum rod [16]. A more recent study reported a failure rate of 47.1% [17], possibly due to too many ARCO III patients was included.

To our knowledge, real-time CT imaging has never been used for any interventions of femoral head necrosis. However, several studies have demonstrated the high utility in various fields, such as interventional radiology and oncology. Real-time CT imaging was able to accurately guide biopsy, aspiration, drainage, and ablation in the brain, chest, and abdomen [18, 19].

Based on the above research, this study was designed to investigate the medium-term clinical effect of intra-operative real-time CT accurate positioning assisted porous tantalum implant after core decompression for the treatment of non-traumatic osteonecrosis of the femoral head in stage I-II of ARCO.

Materials and methods

This study was approved by the ethical committee of local hospital and informed consent was obtained from each patient. All studies were carried out in accordance with the World Medical Association Declaration of Helsinki. From January 2009 to January 2013, 24 patients who met the inclusion criteria were enrolled in our survey.

Inclusion criteria included, aged between 18 and 80 years, osteonecrosis of the femoral head in stage I-II of ARCO, BMI < 30 kg m−2.

Patients were excluded if they were diagnosed with traumatic osteonecrosis of the femoral head; combined with infectious arthritis, rheumatoid arthritis, or osteoarthritis; combined with infection and haemorrhage; unable to tolerate surgery or post-operative treatment; BMI ≥ 30 kg m−2 (Fig. 1).
Fig. 1

Surgical procedures of core decompression and porous tantalum rod implantation. a Hip anteroposterior X-ray showed left femoral head necrosis in ARCO II. b, c Hip coronal and lateral CT showed left femoral head necrosis in ARCO II. df Kirschner wire was used to locate the necrotic lesions in coronal, transverse, and sagittal planes under the guidance of intra-operative real-time CT. g Drill into the femoral head necrosis with a hollow drill under the guidance of the positioning of the Kirschner wire. h X-ray examination of femoral head necrosis after curettage. i Intra-operative observation of femoral head necrosis after curettage. j Porous tantalum rod of suitable size. k Porous tantalum rod implantation. l X-ray fluoroscopy of porous tantalum rod after implantation

Surgical procedures

The schematic diagram of operation is shown in Fig. 2. The exact location and extent of femoral head necrosis were determined by 3D-CT reconstruction and MRI before operation. After spinal anesthesia, a 3 cm incision was made on lateral hip in a supine position. The cortex beneath the trochanter of the left femur was revealed across the lateral femoral muscle; partial periosteum was peeled off. The intersection of the upper part of the lesser trochanter of femur and the lateral femoral cortex was chosen as the insertion point. Firstly, CT 3D C arm X-ray imaging system (SIEMENS, Germany) was used to locate the coronal, transverse, and sagittal planes of the femoral head lesions, and determine the direction of the needle insertion in the three planes. The guide pin was gradually drilled into the lesion of femoral head under the guidance of the imaging system. After confirming that the needle reached the subchondral bone layer of the femoral head, the femoral head decompression and the removal of necrotic lesions were performed with a special drill bit (Zimmer, Inc., Warsaw, IN). Decompression and lesion clearance were again confirmed by the imaging system to reach the subchondral bone layer of the femoral head. The depth gauge was inserted and then the appropriate length of tantalum rod (made of porous tantalum with a diameter of 10 mm and a length of between 70 and 130 mm. The threaded part is 25 mm long, with a diameter of about 14 mm.) (Trabecular Metal Technology, Zimmer, Inc., Warsaw, IN) was placed through the bone tunnel. Finally, CT scan was performed to confirm that the distal end of the tantalum rod close to the subchondral bone layer without penetrating the articular surface, then irrigation hemostasis was performed and the incision was sutured layer by layer (Fig. 1). No drainage tube was placed.
Fig. 2

Schematic diagram of operation. a The needle was inserted into the necrotic lesions under fluoroscopy. b With the aid of 3 dimensional CT, the guide needle reached the centre of the necrotic lesion and the distal end reached the subchondral bone of the femoral head. c, d Diagrams showing the measurement of the distance from the tip of the TM rod to the subchondral bone of the femur head. c, coronal view; b, transverse view. The shorter distance was used for statistical analysis of the relationship between the distance from the tip of the TM rod and postoperative radiographic progression

Post-operative treatment

Two SLE patients and two patients with renal disease were guided to use 5 mg prednisolone for disease control. Patients were instructed to be non-weight-bearing for six weeks, after which point partial weight-bearing with a walking aid was allowed for the following six weeks. All patients were allowed to perform full-weight-bearing walking 12 weeks after the procedure. Patients who had severe pain and or limited functioning after tantalum implant surgery were identified by the surgeons as requiring conversion to THA.

Therapeutic evaluation

The operation time, intra-operative blood loss, and the time of non-weight-bearing walking after operation were recorded. Harris and VAS score of pre-operative, post-operative six months, one year, 1.5 years, two years after surgery, and last follow-up were evaluated. Harris score ≥ 85 at the last follow-up was defined as a clinical success. The imaging success of X-ray referred to patients with necrotic areas replaced by new bone or patients with necrosis progress that not extended to collapse of the femoral head. The aetiology of femoral head necrosis progress were analyzed.

Statistical analysis

Quantitative data was expressed as means ± standards (SD) and compared using the student’s t test. Qualitative data was expressed as percentages and compared using χ2 test. Statistical analysis was performed by SPSS 18.0 software (SPSS Inc.,USA). P < 0.05 was considered statistically significant.

Results

On the basis of the magnitude of the Kerboul combined necrotic angle [20], hips were classified into four categories: grade 1(< 200°), grade 2 (200° to 249°), grade 3 (250° to 299°), and grade 4 (≥ 300°).

Patients’ demographics

Twenty males and four females were enrolled in our study with an average age of 35.38 ± 9.23 years, a BMI of 25.72 ± 2.67 kg m−2. There were 19 unilateral and five bilateral patients. Five patients with ARCO stage I and 24 patients with ARCO stage II. The average combined necrotic angle was 262.10 ± 32.80°, and the mean pre-operative Harris and VAS score was 73.79 and 7.13, respectively (Table 1).
Table 1

Demographics and procedural data for the patients (n = 24)

Case no.

Gender, age(years)

BMI

(kg m−2)

ARCO stage

Angle of femoral head necrosis

 

A

B

CNA

Grade

D1(mm)

D2(mm)

1

M, 32

24.2

L I/R II

120/147

109/115

229/262

2/3

4.1/4

3.8/4.2

2

M, 25

22.4

II

150

152

302

4

5

4.4

3

M, 36

26.3

II

133

140

273

3

4.2

3.6

4

F, 38

23.2

II

144

150

294

3

4.8

0.4

5

M, 44

28.3

II

160

143

303

4

5

5

6

M, 38

21.8

I

112

100

212

2

4.7

3.8

7

M, 45

27.6

II

142

116

258

3

4.5

4.8

8

M, 22

24.8

I

110

123

233

2

5

4.4

9

M, 48

26.6

II

156

154

310

4

5.4

5.2

10

M, 51

22.6

I

103

114

217

2

3.8

4.2

11

M, 33

22.8

II

145

141

286

3

4.4

4.8

12

M, 27

26.6

L I/R II

115/140

104/119

219/259

2/3

5.2/4.7

4.4/4.2

13

M, 48

24.8

L II/R II

127/150

155/152

282/302

3/4

3.8/4.6

4.7/4.2

14

F, 32

28.6

II

133

140

273

3

3.9

4.4

15

M, 44

24.6

L II/R II

154/133

150/146

294/279

3/3

5.3/5.2

5.3/4.6

16

M, 23

30.1

II

160

143

273

3

4.2

5

17

M, 30

31.2

L II/R II

146/160

119/144

265/203

3/4

5.2/5.4

4.8/5.6

18

M, 46

22.7

II

118

123

241

3

4.8

4.3

19

M, 33

29.1

II

142

106

248

3

4.8

4.2

20

F, 36

26.8

I

103

92

195

2

3.8

4.8

21

M, 21

27.3

II

145

101

246

3

4

3.4

22

F, 43

27.2

II

140

124

264

3

4.3

4.8

23

M, 22

22.4

II

154

152

306

4

5

5

24

M, 32

25.2

II

133

140

273

3

4.4

4.8

Improved Kerboul joint angle of femoral head necrosis; CNA combined necrotic angle, Grade grade of combined necrotic angle; D1 and D2 distance between the tip of the tantalum rod and the subchondral bone of the femoral head (mm)

Intra-operative findings

According to the unilateral hip joint statistics, the average operation time was 72.6 minutes (55–106 minutes), increased by about 20–25 minutes compared to conventional surgery (unpublished data). The average volume of intra-operative blood loss was 158.8 ml (110–260 ml). There were no femoral head penetration, incision infection, and delayed wound healing and death case. The average length of hospital stay was 4.6 days (3–5 days).

Clinical outcomes

The patients were followed up for an average of 5.4 years (3.5–7.5 years). Imaging evaluation of avascular necrosis of the femoral head without progression is defined as effective surgery. The effective rate was 86.21% at 12 months. Two among four cases with hormone use were stable in stage III, and no further collapse of femoral head morphology was found at the last follow-up. Two patients (two hips) were converted to THA 2 and fours years after surgery because of femoral head collapse.

At six months follow-up, all patients received varying degrees of pain relief and improved hip function, the functional improvement and pain relief rate was 100%. Pre-operative and post-operative follow-up Harris and VAS scores were shown in Table 2. Increased pain was observed in four cases with hormone use (four hips, one case of SLE, two cases of nephropathy, one case of unknown cause) after eight months.
Table 2

Pre-operative and post-operative follow-up Harris and VAS scores

 

Pre-operative

Post-6 M

Post-12 M

Post-18 M

Post-36 M

Last follow-up

Harris score

73.78

89.93

89.97

89.52

88.28

88.11

VAS score

7.13

2.34

2.07

2.44

2.45

2.66

Radiographic outcomes

There was no radiographic progression in five hips with pre-operative evaluation of stage I; four of 24 hips in stage II progressed into stage III between eight and 12 months after surgery, among which two patients progressed into stage IV at two and 3.5 years after surgery, two cases remained in the stage III at the last follow-up. The mean Kerboul combined necrotic angle was 263.24°. There were six hips with a Kerboul combined necrotic angle of more than 300°, of which four cases had post-operative femoral head necrosis progress, two cases were converted to THA. There was no progress in Kerboul combined necrotic angle in grades 2 and 3 patients. Pre-operative and post-operative radiographic images of three representative cases were shown in Figs. 3, 4, 5.
Fig. 3

Typical case I: hip of a 22-year-old man with bilateral osteonecrosis of the femoral head and a history of drinking. Bilateral hip pain and mild claudication (18 months) was observed pre-operatively. Simultaneous real-time intra-operative CT guided core decompression and porous tantalum rod reconstruction was performed; pain of hip joint relieved and function improved six months after surgery (Harris score: right 91, left 88; VAS score: right 2, left 3). a X-ray showed that the density of bilateral femoral head was uneven and the morphology was complete (right: ARCO stage I; Left: ARCO stage II). bf CT and MRI staging and necrosis area determination: right less than 30% and left 30–50%. gl CT imaging of intra-operative tantalum rod placement: the position of the tantalum rod implanted in the femoral head was located in the weight-bearing area of the necrotic area, achieving the effect of accurate implantation (gi, left hip; jl, right hip). mp X-ray films at six months, 1.5 and three years after surgery showed that there was no collapse of femoral head and necrosis without progress. q, r At the last follow-up (7 years after surgery), CT showed normal femoral head morphology and the tantalum rod and the femoral head cancellous bone was well integrated

Fig. 4

Typical case II: hip of a 45-year-old man with unexplained left osteonecrosis of the femoral head (ARCO stage II, 26 months) accompanied by limited activity. Harris score increased from 73 pre-operatively to the last follow-up of 93, and VAS score decreased from pre-operative 5 to the last follow-up of 2. a, b Pre-operative X-ray and CT showed left femoral head necrosis (ARCO II). c, d Pre-operative MRI showed extensive oedema around the lesions of left femoral head necrosis. eg Intra-operative real-time CT confirmed that the porous tantalum metal rods had been precisely implanted on three planes. h, i 1 year after operation, the X of the left hip joint showed that the femoral head was intact and without deformation. j, k At the end of the follow-up period of 5 years, the left hip X-ray showed no collapse of the femoral head deformation, good bone reconstruction and no narrowing of the hip joint. l The femoral head was morphological normal at the last follow-up (6 years post-operatively). m, n At the last follow-up (6 years after surgery), CT showed that the tantalum rod and the femoral head cancellous bone was well integrated

Fig. 5

Typical case III: hip of a 47-year-old man with bilateral osteonecrosis of the femoral head (Harris score: right 78, left 79; VAS score: right 8, left 8) and a history of glucocorticoid usage for 3 months. a Pre-operative X films showed bilateral osteonecrosis of the femoral head (right: ARCO stage II; left: ARCO stage II). bd CT and MRI staging and necrosis area determination: right less than 50% and left 50%. eh CT results showed that the porous tantalum rod was located in the weight-bearing area of subchondral bone. i Post-operative X films showed satisfactory position of the porous tantalum rod and normal shape of the femoral head. jl CT at 6 months after surgery showed normal shape of the left femoral head and necrosis without progress; weight-bearing area of the right femoral head collapsed and lesions progressed to stage 3. While subchondral bone collapse was not observed at the supporting region of the porous tantalum rod, suggesting a good reconstruction and support. m X-ray showed that the right femoral head collapsed and the joint space narrowed slightly; left femoral head without collapse, the joint space was not narrowed (Harris score: right 68, left 90; VAS score: right 8, left 2). n 1 year after total hip arthroplasty, the right hip joint showed no pain and improved function (Harris score 91; VAS score 1). No collapse was observed in left femoral head 4.5 years after porous tantalum implantation (Harris score 92, VAS score 1)

Discussion

Clinical research has found that the support of subchondral bone plate is of great significance to limit or delay the development of early osteonecrosis, vascularized fibular graft has been used for structural support. For young patients with large amount of exercise, the aim is to protect the shape of femoral head with complete shape and good clearance does not collapse. Trauma, mechanical insufficiency has become one of the important factors to limit the effect of surgery such as free fibula grafting with or without blood vessels, autograft or allogeneic bone grafting, various bone flap implantation procedures, etc. Results showed that porous tantalum rod can reduce the pressure of the subchondral plate and its elastic modulus is similar to that of bone, which results in similar stress and strain in the femoral head.

Common problems (case selection and no precise localization of lesions and implantation) and surgery failure analysis of tantalum rod in clinical research:

Porous tantalum metal rods have excellent biocompatibility, and its internal structure is similar to that of bone. It has high porosity (75–80%); the honeycomb structure makes fast reliable tissue ingrowth, thereby enhancing the revascularization of necrotic area. With the advantages of physiological stress distribution and little stress shielding, it can provide structural support for the femoral head [21, 22]. A failure rate of 56% was reported by Floerkemeier [23] in a group of patients with osteonecrosis of the femoral head treated with core decompression combined with tantalum rod implantation. Of the 11 patients who failed in this study, 4 (36.3%) had ANFH due to femoral neck fracture and 4 (36.3%) had blood and lymphoid malignancies.

Liu et al. suggested that the failure rate was higher in the cases with large femoral head necrosis (cases in stages 3 and 4) [24]. There were individual patients who accept total hip arthroplasty because of no improvement in clinical symptoms although there was no progress in imaging [25]. As early as 2006, Nadeau et al. reported that the failure rates were as high as 55.5% in 15 (18 hips) Steinberg III (3 hips) and IV (15 hips) patients, which noted the importance of appropriate case selection. Zhang et al (2015) reported a survival rate of 64.29% [16], which suggests that the reason for high failure rates may be due to case selection and poor placement of tantalum rods. Ma et al. (2016) reported a high failure rate of 47.1% due to excessive inclusion of ARCO III cases (59.6%) [17]. To sum up, we believe that a reasonable case selection (limited to ARCO I and II) and accurate implantation of tantalum rod in our study is the key reason for achieving a more satisfactory mid-term clinical outcome than previous studies.

Advantage of real-time CT accurate positioning assisted porous tantalum implant

Three-dimensional finite element studies have demonstrated that the porous tantalum rods support the femoral head in a similar manner to fibular grafts, with the same stress and strain modes in the femoral head. The most important role of porous tantalum rods in the femoral head is to withstand pressure, its best position is on the upper side of the femoral head, where it can contact and support the subchondral bone plate [26, 27]. Therefore, accurate positioning of the femoral head necrosis lesions, adequate decompression, implantation of the distal tip of the tantalum rod into the subchondral bone layer of the weight-bearing area of the femoral head necrotic lesion was critical during surgery. Real-time CT precise positioning assisted drilling decompression, lesion grinding, and porous tantalum rod treatment was used in this study. The average operation time was 72.6 minutes, increased by about 20–25 minutes compared to conventional surgery. The average volume of intra-operative blood loss was 158.8 ml (110–260 ml). There was no significant difference in operative time and blood loss compared with the current study. Animal model studies have shown that the strength of the tantalum rod is sufficient to withstand the pressure of the femoral head. Compared to fibula, tantalum rods have a unique biomechanical advantage, with 80% porosity providing a favorable environment for new bone ingrowth [9, 22, 28, 29]. C-arm two-dimensional real-time monitoring used in the implantation of tantalum rod can only be used for general understanding of the position of the tantalum rod, and cannot prove that the tantalum rod has been implanted in the weight-bearing area of the lesion accurately. In this study, 3D imaging evaluation of the location of porous tantalum rod in the subchondral bone plate was used to demonstrate the effectiveness of real-time monitoring of the guided implant; results showed that the bone thickness of the subchondral bone plate was 4.36 mm after tantalum rod implantation. In this study, MRI was used to fully understand the distribution area of femoral head necrosis before operation; 3D imaging was used to guide the needle to the lesion area during operation; the necrotic tissue was abraded with a drill bit; the tip of the tantalum rod was accurately implanted into the subchondral bone layer of the necrotic region to provide a stable environment for the repair of femoral head lesions.

Our study suggested that during cases selection, patients with femoral head necrosis of large area but no collapse (joint necrosis angle > 300°) need to be considered carefully. Study also found that surgical failure rate was higher in the patients with a wide range of edema in the area of femoral head necrosis.

Tantalum rod analysis

As a metal material, tantalum rods are not degradable despite good tissue blending properties [22]. At present, only animal studies have confirmed the condition of bone implantation and whether the high porosity is a vascularized environment. However, the mechanism of tantalum metal involved in vascularization is still unclear. The larger the femoral head necrosis area was, the higher the risk of collapse, and the failure rate of the treatment with tantalum rod was also higher. The space of tantalum rod filling the distal femoral head necrosis of the lesion area is limited. Tantalum rod is not suitable for patients in 3–4 stage of a large area or fan necrosis lesions. In this study, the degree of osteonecrosis was evaluated by the joint necrosis angle of femoral head. Higher post-operative progression rate was observed in patients with joint necrosis angle of > 300° than other groups. More desirable techniques are expected to address the clearance and filling of the AVN 3 lesion in young patients, as well as the support problem of weight-bearing area.

There are some limitations in this study. Firstly, all patients were treated with intra-operative real-time CT accurate rapid positioning assisted drilling decompression, lesion removal, and porous tantalum implant. Secondly, we have no histological evidence that the bone ingrowths into porous tantalum implants. Additionally, further studies with large samples are needed to elucidate the long-term clinical outcomes of real-time CT accurate positioning assisted porous tantalum implant in the treatment of ONFH.

Conclusion

Our results demonstrated that real-time CT accurate positioning assisted porous tantalum implant technique is safe and effective in the treatment of ARCO stage I-II non-traumatic ONFH.

Notes

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical review committee statement

This study was approved by the ethic committee of Xiangya Hospital Central South University and followed the Declaration of Helsinki. Informed consent were received from all patients.

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Copyright information

© SICOT aisbl 2018

Authors and Affiliations

  1. 1.Department of OrthopeadicsPeople’s Hospital of Guizhou ProvinceGuiyangPeople’s Republic of China
  2. 2.Department of OrthopeadicsXiangya Hospital Central South UniversityChangshaPeople’s Republic of China
  3. 3.Department of SurgeryUniversity of PittsburghPittsburghUSA

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