Implant Survivorship and Radiographic Outcomes of Revision Total Ankle Arthroplasty Using a Modular Revision System

Abstract

Background:

With the growing popularity of total ankle arthroplasty (TAA), there is an expectation that revision surgeries will increase. However, limited data exist on revision TAA outcomes using a revision-specific implant. The INVISION Total Ankle Revision System is a modular revision implant (Wright Medical Group/Stryker). The purpose of this study was to report implant survivorship, complications, and radiographic and clinical outcomes of revision TAA using the INVISION system at a minimum 2-year follow-up.

Methods:

A retrospective review was conducted of 27 patients that underwent a revision TAA using the INVISION implant at a single institution with minimum 2-year follow-up between 2016 and 2020. Implant survivorship was the primary outcome. Demographics, complications, reoperation, and radiographic and clinical outcomes were recorded.

Results:

Implant survivorship was 81.5% (22/27) at a mean of 3.6 years following revision TAA using the INVISION implant. There was evidence of aseptic loosening in 3 patients and talar subsidence in 4 patients on final radiographs. Reoperation rate at final follow-up was 40.7%, most commonly for aseptic loosening (n = 3), septic TAA (n = 2), or gutter impingement (n = 2). The mean American Orthopaedic Foot & Ankle Society (AOFAS) total score was 54.5, Foot and Ankle Ability Measure (FAAM) activities of daily living (ADL) subscale score was 52.9, and FAAM Sports was 31.0.

Conclusion:

Revision TAA using the INVISION implant demonstrated 81.5% implant retention at a mean of 3.6 years in this complex cohort. Patient-reported outcomes were lower than those reported after primary TAA. Physicians and patients should recognize that revision TAA remains a challenging procedure with a high rate of complications and reoperations.

Graphical Abstract

This is a visual representation of the abstract.

Keywords

revision total ankle arthroplasty total ankle arthroplasty ankle arthritis

Level of Evidence: Level III, retrospective cohort.

Introduction

With the growing popularity of total ankle arthroplasty (TAA), revision surgeries are expected to significantly increase.^1,2,9 Revision TAA remains challenging with high complication rates.^1,11 Limited data exist on revision TAA using a revision-specific implant. The INVISION Total Ankle Revision System is a modular revision system with theoretical benefits of improved fixation, restoration of joint height, coverage of bone loss, and maximal talar coverage (Wright Medical Group/Stryker). A recent study of the INVISION TAA noted excellent short-term survivorship at 3.5 years with no failures.⁸ The purpose of this study was to describe implant survivorship and clinical and radiographic outcomes of revision TAA at a single institution using the INVISION implant at minimum 2-year follow-up.

Methods

This retrospective chart review examined patients at a single institution who underwent revision TAA using an INVISION talus and/or tibial component between 2016 and 2020 with minimum 2-year follow-up. All patients who underwent revision TAA using the INVISION system were included (Figure 1). Patients with less than 2-year follow-up and unwilling to return to clinic were excluded. A prospectively maintained TAA registry was queried, identifying 27 eligible patients. Two patients were deceased at final follow-up.

Figure 1.

Anteroposterior (AP) and lateral weightbearing radiographs of a patient 18 months postoperative revision total ankle arthroplasty using the INVISION tibial and talar components.

Four fellowship-trained foot and ankle orthopaedic surgeons with extensive TAA experience performed the revision procedures. The revision TAA was performed with an intramedullary-referencing tibial implant and flat-cut talus. The previous components were assessed for loosening. Revision was performed with either an INBONE II (n = 11) or INVISION (n = 16) tibial component and either an INBONE II (n = 7) or INVISION (n = 20) talar component (Table 1). Component cementation was performed at the discretion of the operating surgeon in cases with poor bone stock or extensive bone loss.

Table 1.

Summary of Patients Included in the Case Series.

No.	Age at Revision (y)	Comorbidities	Time From Primary TAA to Revision (mo)	Indication for Revision	Original Implant	Single or 2-Stage	Revision Tibial Implant	Revision Talar Implant	Additional Procedures
1	80	None	111.5	Osteolysis tibia, talus, calcaneus	InBone I	Two-stage with cyst curettage and bone grafting tibia and talus	Invision	Invision	HWR, ICBG, revision STF
2	58	HTN, RA	15.6	Medial malleolus fracture from ground-level fall	Infinity	Single	Invision	InBone II	HWR, ICBG, treatment MM nonunion
3	60	Obesity	21.6	Reimplant after TAA infection	Infinity	Two-stage with cement spacer, negative cultures	Invision	InBone II	TAL, HWR, ICBG
4	56	Obesity	13.9	Aseptic loosening	InBone II	Two-stage with cement spacer, negative cultures	InBone II^a	Invision	Gastrocnemius recession, HWR, ICBG
5	65	MDD, GAD, GERD, HLD, anemia, obesity, prediabetes	6.0	Reimplant after TAA infection	InBone II	Two-stage with cement spacer, RFFF, cultures grew MSSA and GNR	Invision	Invision	None
6	64	HTN, HLD	21.4	Talar subsidence	InBone I	Single stage, negative cultures	Invision	InBone II	TAL, HWR, ICBG
7	46	HTN, HLD	9.8	Aseptic loosening	InBone II	Two-stage with cement spacer, negative cultures	Invision	InBone II	HWR, ICBG
8	52	RA	100.9	Aseptic loosening	Salto Talaris	Two-stage w/ bone grafting, ORIF distal tibia, cement spacer	Invision	InBone II	HWR, ICBG, Cotton osteotomy
9	67	HLD, anemia, hypothyroidism, fibromyalgia	85.9	Talar subsidence	InBone II	Two-stage w/ bone grafting, cement arthroplasty, ORIF calcaneus nonunion, negative cultures	Invision	Invision	HWR, ICBG
10	65	T2DM	29.8	Aseptic loosening	Infinity	Single stage, negative cultures	Invision	Invision	ICBG, PTT lengthening
11	70	HTN, CAD, A-fib, RA, tobacco use	9.2	Reimplant after TAA infection	InBone II	Two-stage w/ cement spacer, RFFF, cement spacer, cultures grew E. cloacae	InBone II	Invision	HWR, ICBG
12	65	Obesity, gastric bypass, cervical myelopathy, MDD, HTN, HLD	36.6	Aseptic loosening	InBone II	Single stage, negative cultures	InBone II^a	Invision	TAL, ICBG, midfoot osteotomy w/ fusion
13	61	HTN, HLD, CAD, T2DM, COPD, obesity	43.5	Reimplant after TAA infection	InBone II	Two-stage w/ cement spacer, RFFF, negative cultures	Invision	Invision	HWR, ICBG
14	57	HTN, CHF, T2DM, RA, DVT	111.1	Talar subsidence	InBone I	Single stage, negative cultures	InBone II	Invision	HWR, ICBG
15	52	Anemia, colon cancer	39.7	Aseptic loosening	Infinity	Single stage, negative cultures	InBone II	Invision	ICBG
16	59	HTN, HLD, CHF, MDD, GERD, IBS, PE	129.9	Heterotopic ossification	InBone I	Single stage, negative cultures	Invision	Invision	ICBG
17	56	Asthma, MDD, hypothyroidism	40.2	Aseptic loosening	Infinity	Single stage, negative cultures	Invision	InBone II	HWR, ICBG, prophylactic fixation of MM
18	57	HTN, HLD, CAD, T2DM, MDD	15.4	Aseptic loosening	Infinity	Single stage, negative cultures	Invision	Invision	ICBG
19	67	HLD	82.9	Aseptic loosening	InBone I	Two-stage w/ cement spacer, negative cultures	Invision	Invision	HWR, ICBG
20	50	HTN, HLD, T2DM, CAD, fibromyalgia	42.3	Aseptic loosening	InBone II	Single stage, negative cultures	InBone II^a	Invision	Gastroc recession, HWR, ICBG, prophylactic fixation of MM
21	68	HTN, HLD, CAD, T2DM, fibromyalgia	55.2	Talar subsidence	InBone II	Single stage, negative cultures	InBone II^a	Invision	HWR, ICBG
22	65	HTN, HLD, obesity	56.8	Talar subsidence	Infinity	Single stage, negative cultures	Invision	Invision	HWR
23	50	Obesity, OSA	63.2	Talar subsidence	Infinity	Single stage, negative cultures	Invision	Invision	HWR, ICBG
24	55	HTN, HLD, obesity	95.2	Heterotopic ossification	InBone I	Single stage, no cultures obtained	InBone II	Invision	ICBG
25	68	HTN, CKD, CAD, PAD, obesity	114.5	Talar subsidence	InBone I	Two-stage w/ bone grafting, polyethylene spacer, negative cultures	Invision	Invision	ICBG, prophylactic fixation of MM
26	73	HTN, HLD, hypothyroidism, COPD	7.3	Periprosthetic fracture	Infinity	Two-stage w/ bone grafting, ORIF distal tibia, cement spacer, negative cultures	Invision	InBone II	TAL, HWR, ICBG, ORIF tibia fracture
27	72	HTN, HLD, tobacco use	28.0	Aseptic loosening	Infinity	Single stage, negative cultures	InBone II	Invision	HWR, ICBG

Abbreviations: CAD, coronary artery disease; CHF, congestive heart failure; CKD, chronic kidney disease; COPD, chronic obstructive pulmonary disease; DVT, deep vein thrombosis; GAD, generalized anxiety disorder; GERD, gastroesophageal reflux disease; HLD, hyperlipidemia; HTN, hypertension; HWR, hardware removal; IBS, irritable bowel syndrome; ICBG, iliac crest bone graft; MDD, major depressive disorder; MM, medial malleolus; ORIF, open reduction internal fixation; OSA, obstructive sleep apnea; PAD, peripheral artery disease; PE, pulmonary embolus; PTT, posterior tibial tendon; RA, rheumatoid arthritis; RFFF, radial forearm free flap; STF, subtalar fusion; TAA, total ankle arthroplasty; TAL, tendo-Achilles lengthening; T2DM, type 2 diabetes mellitus.

InBone II tibia from index TAA was retained at the time of revision surgery.

Indications for revision TAA included aseptic loosening (n = 11), talar subsidence (n = 7), reimplant after infection (n = 4), periprosthetic fracture (n = 2), heterotopic ossification (n = 2), and osteolysis (n = 1). All patients underwent concomitant procedures at time of revision TAA (Table 1). The tibial component was cemented in 14.8% of patients (4/27), and the talus was cemented in 44.4% of patients (12/27).

The primary outcome was implant survivorship defined as retention of metal components at final follow-up. Additional procedures, complications, and reoperation were recorded. Clinical outcomes included Foot and Ankle Ability Measure (FAAM) activities of daily living and sports subscales, along with total American Orthopaedic Foot & Ankle Society (AOFAS) scores. Weightbearing radiographs were assessed for osteolysis, loosening, subsidence, and component alignment. Aseptic loosening was determined by progressive lucency greater than 2 mm at follow-up and confirmed intraoperatively by manually testing the implants for stability. Osteolysis was defined as a cyst greater than or equal to 5 mm. This is usually observed without subsidence initially (Figure 2).

Figure 2.

An example of osteolysis of the talus.

Statistical Analysis

Descriptive statistics with means and SDs for continuous variables, and ratios and percentages for categorical variables. Analysis was conducted using SAS (SAS Institute, Cary, NC) with P value <.05 considered significant. Comparisons between cemented and uncemented groups were performed using Fisher exact test.

This study was approved by the Wake Forest University Institutional Review Board (IRB) with a protocol number of IRB00090483.

Results

The study included 27 patients with a mean age of 61.4 ± 8.1 years, 63.0% male (17/27), who underwent revision TAA using INVISION tibia and/or talus implant (7 tibia only, 9 talus only, 11 combined). Implant survivorship was 81.5% (22/27) at a mean of 3.6 years. The average time from index TAA to revision using INVISION was 4.3 years (range 7 months to 10.8 years). Only 4 patients had a cemented tibial component with 1 implant failure noted, making it difficult to draw conclusions given the small sample size. To our knowledge, this is the first study to examine cementing of the tibial and/or talar component in revision TAA using the INVISION implant.

Radiographic Outcomes

All patients had neutral coronal and sagittal alignment on final radiographs. The median coronal tibiotalar angle (TTA) was 89.5 degrees (interquartile range 88, 90.9). The mean coronal distal tibia component angle (DTCA) and sagittal DTCA were 89.6 ± 1.7 degrees and 87.6 ± 1.6 degrees, respectively, at final follow-up. On final radiographs, aseptic loosening was noted in 3 patients (11.1%), talar subsidence in 4 patients (14.4%), and tibial and talar osteolysis in 4 patients (14.4%).

Patient-Reported Outcome Measures

At final follow-up, the mean FAAM activities of daily living was 52.9 ± 22.2 and mean FAAM sports was 31.0 ± 20.9. Average AOFAS total score was 54.5 ± 25.7.

Reoperation

The reoperation rate at final follow-up was 40.7% (Table 2), most commonly for aseptic loosening (n = 3), septic TAA (n = 2), gutter impingement (n = 2), instability (n = 1), medial malleolus stress fracture (n = 1), talar subsidence (n = 1), and wound dehiscence (n = 1). There were no intraoperative complications noted. Implant survivorship at final follow-up was 81.5% (22/27). Postoperative complications as described by Glazebrook et al³ are described in Table 3.

Table 2.

Reoperation Numbers, Indication, and Reoperation Procedures Following Revision TAA.

No.	Reoperation	Reason for Reoperation	Time to Reoperation (mo)	Component Involvement	Reoperation Procedure
3	Yes	Medial malleolus stress fx	11.9	N/A	Open treatment medial malleolus
4	Yes	Valgus instability	4.1	N/A	HWR, conversion TTC fusion
5	Yes	Aseptic loosening	22.8	Talus	Revision TAA, talus only
7	Yes	Aseptic loosening	12.7	Tibia/Talus	Revision TAA, tibia and talus
11	Yes	Instability, gutter impingement	27.1	N/A	Brostrom, lateral gutter debridement
13	Yes	Septic TAA	45.3	N/A	I&D and poly exchange
14	Yes	Draining wound	1.3	N/A	Free flap
15	Yes	Talar subsidence	47.4	Talus	Revision TAA, talus only
17	Yes	Aseptic loosening	21.2	Tibia	Revision TAA, tibia and talus
18	Yes	Septic TAA	26.4	N/A	I&D and poly exchange, free flap
24	Yes	Instability, gutter impingement	26.2	N/A	TAL, gutter debridement, Brostrom

Abbreviations: Fx, fracture; HWR, hardware removal; I&D, irrigation and debridement; TAA, total ankle arthroplasty; TTC, tibiotalocalcaneal.

Table 3.

Postoperative Complications as described by Glazebrook et al.³

Complication	^aNO (N = 25)	%
High-grade complications
1. Aseptic loosening	11	41
2. Deep infection	4	15
3. Implant failure	–	–
Medium-grade complications
4. Subsidence	7	26
5. Postoperative fracture	2	7
6. Technical error	–	–
Low-grade complications
7. Superficial infection	–	–
8. Delayed wound healing	–	–
9. Intraoperative prosthetic fracture	–	–

The 2 cases of heterotopic ossification and 1 case of osteolysis were not included in this table.

Discussion

With the growing popularity of TAA, understanding the challenges, survivorship, and complications of revision TAA is essential. Historically, failed TAA was treated with conversion to fusion, often associated with poor outcomes and high nonunion rates.^4,5 The introduction of modular revision-specific TAA implants has provided additional surgical options for these complex cases.

Recent studies on early implant survivorship of revision TAA using the INVISION implant have reported excellent survivorship with low complication and reoperation rates.^7,8 Purnell et al⁸ reported 100% implant survivorship rate in 19 patients at mean follow-up of 3.5 years with no reoperations. Similar results were reported by Martin et al⁷ in 17 patients at mean follow-up of 3.4 years noting 100% implant retention with 1 patient undergoing reoperation. A study of 28 patients undergoing revision TAA using the INVISION talus noted a 10.7% rate of reoperation and 10.7% implant failure at 1.3 years.¹⁰ Implant survivorship in our study was 81.5% at a mean of 3.6 years, still good given the complex nature of revision TAA but lower than previous reports. Our higher complication rate is likely multifactorial in nature. This group of patients was treated with the Invision system, which is generally used for more complex revisions with more bone loss and fixation challenges, therefore excluding easier revision cases. Moreover, alternative surgical options for these patients remains limited and typically include either a complex fusion/reconstruction or amputation. The small sample sizes of our study and other similar studies should also be taken into account as a different outcome for 1 or 2 patients can drastically skew the results of the study.

Reoperation rates at final follow-up in our study were 40.7% for revision TAA using the INVISION system, higher than previously reported.^5-7 Martin et al⁷ did note an overall complication rate of 39.3% at 1.3 years using INVISION talus, despite the lower 10.7% rate of reoperation. The most common complications after revision TAA in our study were due to aseptic loosening (11.1%), septic TAA (7.4%), and gutter impingement (7.4%).

Among patients with a cemented talar component, implant survivorship at final follow-up was 91.7%, compared with 73.3% in the uncemented group. The use of cement should be considered in patients undergoing revision TAA, with many of these patients having significant bone loss and poor overall bone stock. Revision rates for the patients with cement compared to the noncement group can be found in Table 4.

Table 4.

Component Cementation Rates and Subsequent Revision Rates.

	Tibia Component Revised		P Value
	No	Yes
Tibial component cemented
No	22 (84.6)	1 (100.0)	>.99
Yes	4 (15.4)	0 (0.0)
	Talus Component Revised
	No	Yes
Talus component cemented
No	12 (50.0)	3 (100.0)	.2308
Yes	12 (50.0)	0 (0.0)

The mean FAAM Activities of Daily Living, FAAM Sports, and average AOFAS total scores were acceptable, but lower than previously reported literature in patients who underwent primary TAA (Table 5). Lachman et al⁶ noted similar findings in their series of 29 revision TAA, noting that improvements in PROMs were higher after primary TAA than after revision TAA. The lower PROMs observed in our study are likely due to the revision nature of the surgery as well as complexity with implant failure.

Table 5.

Patient-Reported Outcome Measures.

Variable (number of patients)	Mean (SD)
AOFAS total score (14)	54.5 (25.7)
FAAM ADL (19)	52.9 (22.2)
FAAM Sports (18)	31 (20.9)

Abbreviations: AOFAS, American Orthopaedic Foot & Ankle Society; ADL, activities of daily living; FAAM, Foot and Ankle Ability Measure.

Follow-up median: 3.08 years (interquartile range 2.5-4.3), range 1.8-7.2 years.

This study has several limitations. The retrospective nature is subject to recall bias. Despite the small sample size and relatively short follow-up, reporting the high complication rates in this complex cohort is important. Small sample size potentially limits the generalizability of our results. Short follow-up could also underestimate the rate of failure in the long term. The surgeons at our institution have extensive experience with TAA and helped design the INVISION system, making generalizability difficult. Preoperative PROMs were not available for review, making it difficult to assess clinical improvements after revision TAA. Finally, patient retention was an issue given our institution is a tertiary referral center, with several patients traveling long distances making selection bias a concern.

Conclusion

Revision TAA with the INVISION system resulted in 81.5% implant retention at early follow-up in a complex cohort. Although this approach offers an alternative to fusion or amputation, patients and physicians should be aware of the associated high complication and reoperation rates. Further studies with larger cohorts and longer follow-up are needed to clarify the durability and comparative effectiveness of this system.

Supplemental Material

sj-pdf-1-fai-10.1177_10711007251352529 – Supplemental material for Implant Survivorship and Radiographic Outcomes of Revision Total Ankle Arthroplasty Using a Modular Revision System

Supplemental material, sj-pdf-1-fai-10.1177_10711007251352529 for Implant Survivorship and Radiographic Outcomes of Revision Total Ankle Arthroplasty Using a Modular Revision System by Justin J. Ray, William B. Haynes, G. Dillon Graham, Samuel E. Ford, Carroll P. Jones, Bruce E. Cohen, W. Hodges Davis and Robert B. Anderson in Foot & Ankle International

Footnotes

Ethical Approval

Ethical approval for this study was obtained from Wake Forest School of Medicine IRB (IRB00090483).

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Justin J. Ray, MD, reports disclosures relevant to manuscript from Stryker: support for attending meetings and/or travel. Samuel E. Ford, MD, reports disclosures relevant to manuscript from Stryker: consulting and general disclosures from 2022-22215-S AOFAS Grant $15,300. Carroll P. Jones, MD, reports disclosures relevant to manuscript from Stryker: royalties, consulting fees and general disclosures. Bruce E. Cohen, MD, reports disclosures relevant to manuscript from Stryker: royalties, consulting, support for attending meetings and general disclosures. W. Hodges Davis, MD, reports disclosures relevant to manuscript from Stryker: royalties, consulting, support for attending meetings, stock. Robert B. Anderson, MD, reports disclosures relevant to manuscript from Stryker: royalties, consulting and general disclosures. Disclosure forms for all authors are available online.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

G. Dillon Graham, MD,

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