Interventional procedure overview of synthetic cartilage implant insertion for first metatarsophalangeal joint osteoarthritis (hallux rigidus)

Akoh CC, Chena J, Kadakia R et al. (2020) Adverse events involving hallux metatarsophalangeal joint implants: Analysis of the United States Food and Drug Administration data from 2010 to 2018, Foot and Ankle Surgery, https://doi.org/

10.1016/j.fas.2020.05.002

Case series

Among 64 reported hallux MTPJ implant adverse events, 15 (23.4%) were associated with synthetic cartilage implants. Of the 15 events, 5 were inflammation and 5 were component loosening or subsidence. There were 2 reports each of infection and component fracture and 1 report of dislocation.

Another review of the FDA MAUDE database is included (Metikala S, 2020).

Baumhauer JF, Daniels T, Glazebrook M (2019) New technology in the treatment of hallux rigidus with a synthetic cartilage implant hemiarthroplasty. The Orthopedic Clinics of North America 50: 109–118

Review

Synthetic cartilage implant surgery is an excellent option for the patient with great toe arthritis and good alignment of the toe who wishes to retain first metatarsophalangeal motion and obtain 90% improved pain relief and function. Patients with osteoporosis, osteopenia, or bone defects from surgery or disease may not maintain the implant position due to poor bone quality, resulting in less than desired outcomes. Despite this being a straightforward surgery, patients need to be aware that the pain relief may not begin until 3+ months after surgery because this procedure does require bone resection and implant placement.

Review mainly focuses on technique. The relevant cited studies have been included.

Baumhauer JF, Marcolongo M (2016) The science behind wear testing for great toe implants for hallux rigidus. Foot and Ankle Clinics 21: 891–902

Review

A variety of implant materials have been tried to decrease pain and improve function after cartilage repair. The hydrogel made of polyvinyl alcohol and saline is a unique material used as an implant in the great toe for advanced stage arthritis.

Review mainly focuses on wear testing. The relevant cited studies have been included.

Baumhauer JF, Singh D, Glazebrook M et al. (2017) Correlation of hallux rigidus grade with motion, VAS pain, intraoperative cartilage loss, and treatment success for first MTP joint arthrodesis and synthetic cartilage implant. Foot and Ankle International 38: 1175–82

RCT (Motion study)

n=202

FU=24 months

Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors.

Subanalysis of RCT already included (Baumhauer et al., 2016), which focuses on use of grading system for hallux rigidus.

Bernasconi A, De Franco C, Iorio P et al. (2020) Use of synthetic cartilage implant (Cartiva R) for degeneration of the first and second metatarsophalangeal joint: what is the current evidence? Journal of Biological Regulators and Homeostatic Agents 34: 15–21

Review

Although some studies suggest that the use of Synthetic Cartilage Implant (Cartiva) is effective in the treatment of hallux rigidus in providing symptoms relief without sacrifice of joint motion, the redundancy of cohorts reported in studies and the frequency of conflict of interest reported by authors weaken the strength of evidence available and warrant further studies.

Review

Carpenter B, Klemeyer L (2020) Motion preservation in hallux rigidus after failure of hydrogel implantation: treatment considerations and a report of 2 cases. The Journal of Foot & Ankle Surgery 59: 162–8

Case series

n=2

Revision of failed hydrogel implants to arthrodesis can be performed through various first MTP fusion techniques or with a fourth-generation threaded hemiarthroplasty.

Study describes treatment of 2 patients who had a failed hydrogel implant.

Chang TJ (2018) The role of polyvinyl alcohol in cartilage repair of the ankle and first metatarsophalangeal joint. Clinics in Podiatric Medicine and Surgery 35: 133–43

Review

The Cartiva implant is an exciting option in dramatically diminishing patient symptoms in advanced stages of hallux rigidus as well as allowing continued joint motion. It is a procedure that does not burn many bridges in case a future revision to an arthrodesis is necessary

Review mainly focuses on technique. The relevant cited studies have been included.

Daniels TR, Younger ASE, Penner MJ et al. (2017) Midterm outcomes of polyvinyl alcohol hydrogel hemiarthroplasty of the first metatarsophalangeal joint in advanced hallux rigidus. Foot and Ankle International 38: 243–47

Case series

n=27

FU=mean 5 years

Postoperative active MTP natural joint dorsiflexion and peak MTP dorsiflexion were mean 18.2 (range, 10.0-30.0) and 29.7 (range, 10.0-45.0) degrees, respectively. Pain VAS, SF-36 PCS, FAAM ADL, and FAAM Sports scores demonstrated clinically and statistically significant improvements. Radiographically, no patient demonstrated changes in implant position, implant loosening or subsidence, or implant wear. One implant was removed because of persistent pain and converted to fusion 2 years after the procedure.

A more recent report with more patients is included (Glazebrook et al., 2019).

Davies MB, Roberts VI, Chadwick C et al. (2020) Revision of synthetic cartilage implant hemiarthroplasty of the great toe to metatarsophalangeal joint arthrodesis: technique and indications. Techniques in Foot and Ankle Surgery 19: 48–55

Case series

n=3

There were no complications in the 3 patients who had conversion of synthetic cartilage implant hemiarthroplasty to arthrodesis.

Revision surgery of this implant is not technically challenging and has minimal or modest bone loss compared to the techniques described in the literature for other devices.

Study describes revision surgery of 3 patients after implant failure.

Galois L, Hemmer J, Ray V et al. (2020) Surgical options for hallux rigidus: state of the art and review of the literature. European Journal of Orthopaedic Surgery and Traumatology 30: 57–65

Review

Newer techniques of interpositional arthroplasty as well as new hemi-arthroplasty designs, including synthetic cartilage implants, offer promising options for preservation of motion. The choice of procedure is based on the condition of the joint, patient's goals and expectations of the surgical outcome, and patient's motivation.

The relevant cited studies have been included.

Glazebrook MA (2019) Cartiva hemi arthroplasty for treatment of Hallux Rigidus: Surgical technique, evidence and tips and tricks. Fuss und Sprunggelenk 17: 28–32

Review

Recently a motion sparing surgical treatment option with Cartiva hemiarthroplasty for treatment of Hallux Rigidus has been proven to be as safe and effective as arthrodesis in a level I randomised controlled trial. Further, subsequent studies have shown that safety and efficacy of Cartiva hemiarthroplasty has been sustained to mid term follow-up out to five years.

The relevant cited studies have been included.

Glazebrook M, Younger ASE, Daniels TR et al. (2018) Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time. Foot and Ankle Surgery 24: 440–47

Retrospective case control study

n=202

FU=24 months

First MTP joint hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis.

Subanalysis of RCT already included (Baumhauer et al., 2016), which focuses on operative and recovery time.

Lunati M, Mahmoud K, Kadakia R et al. (2021) Complications associated with the surgical management of hallux rigidus. The Orthopedic Clinics of North America 52: 291–96

Review

The early literature supports the use of synthetic cartilage implants with low rates of complications (<10%); however, later studies revealed less successful results with higher rates of revision and postoperative pain.

Review

Shi E, Todd N, Rush S et al. (2019) First metatarsophalangeal joint space area decreases within 1 month after implantation of a polyvinyl alcohol hydrogel implant: a retrospective radiographic case series. The Journal of Foot & Ankle Surgery 58: 1288–92

Case series

n=27

FU=5 to 12 weeks

The difference between the preoperative joint space and the second postoperative joint space was not statistically significant (p=0.398).

There was 1 revision to arthrodesis at 5 months postoperatively because of persistent pain.

Studies with more patients or longer follow-up are included.

Shimozono Y, Hurley ET, Kennedy JG (2020) Early failures of polyvinyl alcohol hydrogel implant for the treatment of hallux rigidus. Foot and Ankle International

doi: 10.1177/1071100720962482

Case series

n=11

FU=mean 21 months

The mean VAS score showed improvement from 4.1 to 3.0 (p=0.012). On postoperative plain radiographs, implant subsidence was observed in 60% (6/10) at 4 weeks after surgery and 90% (9/10) at the final follow-up. 50% (5/10) showed radiologic lucency around the implant. 40% (4/10) had erosion of the proximal phalanx of the great toe. 4 patients (36%) reported no improvement at the final follow-up, which were considered as failures. 3 patients needed additional surgery related to the implants. An additional patient is waiting for an implant revision.

Studies with more patients or longer follow up are included.

Smyth NA, Murawski CD, Hannon CP et al. (2020) The use of a synthetic cartilage implant for hallux rigidus: a systematic review. Foot & Ankle Specialist 1938640020937160

Systematic review

7 studies

Seven studies met the inclusion criteria, 6 of these were derived from a single randomised controlled trial. A moderate recommendation can be given for the use of a polyvinyl alcohol implant for hallux rigidus based on short-term outcomes. A limited recommendation can be given for the use of a polyvinyl alcohol implant for hallux rigidus based on mid-term outcomes.

No meta-analysis. All the studies are included in the overview.

Younger A, Glazebrook M, Daniels T et al. (2021) First Metatarsophalangeal joint polyvinyl alcohol hydrogel implant hemiarthroplasty: current operative technique. Techniques in Foot & Ankle Surgery

Review

In patients with pain localised within the first MTP joint, normal bone stock, and a well-aligned MTP joint, PVA hydrogel implant hemiarthroplasty resulted in reduced pain and improved function.

The outcomes of PVA hydrogel implant hemiarthroplasty need to continue to be monitored and compared against the alternatives of fusion or cheilectomy in isolation. Monitoring of retrieved implants to determine wear characteristics and causes of failure will assist in determining if osteolysis of the bone or degradation of the implant are observed.

Review

Younger ASE, Baumhauer JF (2013) Polyvinyl alcohol hydrogel hemiarthroplasty of the great toe: Technique and indications. Techniques in Foot and Ankle Surgery 12: 164–69

Review

Potential complications of surgery include wound healing problems, implant subsidence, metatarsal head fracture, dorsal medial great toe numbness, and persistent pain.

The procedure preserves more bone, maintains motion in the joint, reduces rehabilitation time, and enables patients to return to normal activity sooner than with fusion. Although early results are promising, further studies currently underway are required to determine the factors associated with success.

Review mainly focuses on technique.

Zanzinger C, Harrasser N, Gottschalk O et al. (2021) One-year follow-up results with hydrogel implant in therapy of hallux rigidus: case series with 44 patients. Zeitschrift fr Orthopdie und

Unfallchirurgie DOI 10.1055/a-1365-9655

Case series

n=44

Follow up: 1 year

The overall survival rate of the implant was 93% at 12 months. The VAS, European Foot and Ankle Society and American Orthopaedic Foot and Ankle Society scores showed a statistically significant improvement in comparison to the preoperative condition. The mobility of the MTP joint showed no increase. Patients with a medium osteoarthritis grade and a medium level of clinical restraint showed the greatest improvement in relation to their preoperative condition.

Small case series with short follow up.