Clinically Proven Joint Replacement for Big Toe Arthritis (Hallux Rigidus)

The BioPro Hemi Toe Implant is a joint resurfacing implant designed to maintain motion and provide pain relief for patients suffering from big toe arthritis. The implant has been successfully used for over 70 years and is supported by published clinical studies worldwide.1-12

Understanding Hallux Rigidus

Osteoarthritis of the big toe is one of the most common conditions of the foot and ankle. The big toe, referred to as the first metatarsophalangeal or MTP joint, is made of two bones, a phalanx and metatarsal.

The big toe joint plays an important role in walking as it bends with every step you take. When suffering from osteoarthritis, the MTP joint becomes stiff and painful, which may change the way you walk and activities you can perform. The medical term to describe this loss of motion is Hallux Rigidus. It is a degenerative disease that can affect people of all ages but most common in people over the age of 50.

In a normal joint, the bone surfaces are covered in cartilage, a tough protective cushion that allows the joint to move easily.  Overtime, due to wear-and-tear, trauma or joint mechanics, cartilage begins to wear down, causing the bone surfaces to rub together. As a result of the cartilage damage, the joint space narrows and osteophytes or bony outgrowths begin to form. In the early stages of the disease, the cartilage damage and osteophyte formation typically occur on the top of the metatarsal head, therefore causing pain while walking or pulling the toe back. As the disease progresses, the more cartilage damage occurs, spreading throughout the joint and eventually resulting in complete overgrowth, and a stiff joint.

The symptoms of hallux rigidus include:

  • Joint tenderness
  • Swelling and inflammation around the joint
  • Difficulty wearing shoes due to bone spur development (overgrowths)
  • Dull pain in other areas of the body (hip, knee, lower back) due to changes in the way you walk

When diagnosing hallux rigidus your surgeon will look for reduced range of motion, especially while pulling the toe up (dorsiflexion) and try to feel for any osteophyte formation. X-rays are the most common method to determine the severity of the disease and determine which treatment options may be best for you.

Before considering surgery there are always non-operative treatments such as:

  • Shoe modifications
  • Orthotics
  • Cast immobilization with a reduction in activity
  • Anti-inflammatory drugs
  • Physical therapy
  • Local injections

Surgical Treatments

Ultimately, surgical treatment is based on a variety of factors including age, stage of arthritis, and activity levels. Depending on a surgeon’s experience and training, they also may have a preferred surgical procedure that they specialize in.  When compared directly to fusion, BioPro patients displayed higher satisfaction rates, lower pain scores, and quicker return to work and leisure activities.1

BioPro Hemi

  • Resurfaces one side of the joint with a smooth metal implant
  • Allows immediate weight-bearing after surgery†
  • Maintains motion in the big toe
  • Allows for a variety of footwear choices, such as heels
  • Allows quick return to work and activities1
  • Can easily be revised 12-13
  • Provides predictable pain relief 1-12

Fusion

  • Removes all cartilage and fuses the bones together with plates or screws
  • Non-weight bearing after surgery
  • Eliminates motion in the big toe
  • Footwear restrictions
  • Immobilization of 6-8 weeks
  • Limited revision options
  • Provides predictable pain relief

Additional Procedures

Cheilectomy

A cheilectomy involves remodeling of the metatarsal head to remove painful bone spurs and is often used in mild cases. While the procedure can improve the toe’s range of motion, the damaged articular cartilage surfaces will still rub against each other and may still be painful. This procedure is often only a temporary solution as it doesn’t stop the progression of arthritis. If a Cheilectomy has been performed in the past, a BioPro Hemi may still be used to resurface the proximal phalanx.

Osteotomy

An osteotomy involves removing a piece of bone from either the metatarsal or proximal phalanx to allow for joint decompression and realignment. This may be performed in conjunction with an implant or stand-alone procedure. Just like a Cheilecomty, if one of the arthritic cartilage surfaces is not replaced with an implant, the procedure won’t stop the progression of arthritis.

Learn what treatments may be right for you.

Find a Surgeon

Fill out the contact form or call us at 810-982-7777 to see if there is an experienced surgeon in your area.

Consult with your surgeon

Discuss all your possible treatment options and expectations after surgery.

Undergoing joint replacement

Joint replacement surgery with the BioPro First MPJ Hemi is an outpatient procedure. You should be in and out in one day and on the road to recovery.


Recovery

Below is the typical timeline for patients after undergoing a hemiarthroplasty with the BioPro Hemi. Each patient’s recovery may be different. Please discuss your protocol with your surgeon prior to surgery.

Immediate weight-bearing

Walk the day of surgery in a post-op shoe

2-4 Weeks

Transition to comfortable shoes

6-8 Weeks

Resume normal activities and sports

A Look at the Long-term Data

Range of Motion

95%

95% of patients had restored range of motion

Revisions before 20 years

5%

Less than 5% of patients required revision surgery before 20 years

Revisions after 20 years

0

No patients required revision after 20 years

Data is based on a clinically published study reviewing 279 patients (256 patients <20 years and 23 patients >20 years) that underwent the BioPro Hemi over a 40 year period. View studies here.

Am I a Candidate?

The BioPro Hemi Is recommended for patients over the age of 50 suffering from hallux rigidus/limitus who wish to maintain motion in their big toe. BioPro cautions use if suffering from other conditions including hallux valgus and sesamoid arthritis.

F.A.Q’s

Yes, most insurance plans cover the procedure. The BioPro Hemi is considered medically necessary for patients suffering from hallux rigidus once conservative treatments have failed. It is still always recommended to get a pre-authorization from your insurance company prior to surgery.

Most patients have a rapid recovery and have considerably less pain than they did before surgery. Partial to full weight-bearing is permitted at the discretion of the surgeon. A standard post-operative shoe may be used for the first 2-3 weeks. Dressings are changed for 3 weeks, with sutures usually removed at the 2-week period. Passive range of motion, such as movement of the toe upward or downward is permitted by the 2nd or 3rd post-operative week. Physical therapy and return to soft shoes are usually permitted by the 3rd to 4th post-operative week.

Note: dressing changes, return to regular shoes and types of postoperative range of motion therapies may vary based on your surgeon’s recommendations.

Just like hip and knee implants, joint implants may require additional surgery sometime in the future. A common misconception is that implants often must be revised after a few years. While this may be true with some implant designs, the BioPro Hemi has clinical data on patients 20-30 years post-op.

Unlike implants that replace both sides of the joint, the BioPro Hemi is extremely thin (similar thickness to a coin) and doesn’t require much bone removal. This design has been proven to allow for an easy revision if ever necessary.

Fill out our Find a Surgeon form to see if there is an experienced surgeon in your area. You can also download our guide to bring to your preferred foot and ankle surgeon.

Although new studies are beginning to favor hemiarthroplasty, the fusion is considered the “Gold Standard” procedure for treating Hallux Rigidus, so many surgeons prefer this procedure. Many surgeons are not aware of the clinical studies supporting our implant. Also, there are many other implants currently on the market for surgeons to choose from, so your surgeon may be using another implant.

Just like with fusion, revision surgery may be required in cases of continued discomfort or irritation. This may be due to implant loosening, joint stiffness, or adjacent arthritis. Since the procedure removes very little bone, data shows that if revision is required, results similar to primary fusion can be expected.14

First, a small piece of bone similar to the size and thickness of the implant is removed from one side of the joint (proximal phalanx). The surgeon will then remove any osteophytes from the metatarsal head keeping any remaining cartilage intact. After using specialized instrumentation to determine the best size, the final implant will be press-fit into the bone providing a smooth durable surface for the metatarsal head to articulate on.

  1. Beekhuizen SR, Voskuijl T, Onstenk R. Long-Term Results of Hemiarthroplasty Compared With Arthrodesis for Osteoarthritis of the First Metatarsophalangeal Joint. J Foot Ankle Surg. 2018 May-Jun;57(3):445-450. doi: 10.1053/j.jfas.2017.10.013. Epub 2018 Feb 1. PMID: 29366661. (View Study)
  2. Karin H. Simons, MD, Pieter van der Woude, MD, Frank W.M. Faber, MD, PhD , Paulien M. van Kampen, PhD , Bregje J.W. Thomassen, PhD. Short-Term Clinical Outcome of Hemiarthroplasty Versus Arthrodesis for End-Stage Hallux Rigidus. The Journal of Foot & Ankle Surgery xxx (2015) 1–4 (View Study)
  3. Giza E, Sullivan MR. First Metatarsophalangeal Hemiarthroplasty for Grade III and IV Hallux Rigidus Techniques in Foot and Ankle Surgery 4(1):10-17,2005
  4.  Clement, N. D., MacDonald, D., Dall, G. F., Ahmed, I., Duckworth, A. D., Shalaby, H. S., & McKinley, J. (2016). Metallic hemiarthroplasty for the treatment of end-stage hallux rigidus. Bone Joint J, 98-B(7), 945-951. (View study)
  5. Taranow, DO. et al. Contemporary Approaches to Stage II and III Hallux Rigidus: The Role of Metallic Hemiarthroplasty of the Proximal Phalanx. Foot and Ankle Clinics , Volume 10 , Issue 4 , 713 – 728
  6. Roukis TS, Townley, MD. BIOPRO resurfacing endoprosthesis versus periarticular osteotomy for hallux rigidus: short-term follow-up and analysis. Journal of Foot & Ankle Surgery 2003;42(6):350-8
  7. Juan C. Goez, DPM, Charles O. Townley MD, Warren Taranow, DO. An Update on the Metallic Hemiarthroplasty Resurfacing Prosthesis for the Hallux. Presented at the 56th Annual Meeting and Scientific Seminar of the American College of Foot and Ankle Surgeons. Orlando FL February 1998
  8. Charles G. Kissel, DPM, FACFAS, Zeeshan S. Husain, DPM AACFAS, Paul H. Wooley, PhD, Michael Kruger, MS, Mark A. Schumaker, DPM, Michael Sullivan, DPM, and Todd Snoeyink, DPM. A Prospective Investigation of the Biopro® Hemi-Arthroplasty for the First Metatarsophalangeal Joint. The Journal of Foot & Ankle Surgery 47(6):505–509, 2008
  9. Taranow, DO , Townley, MD. Metallic proximal phalangeal hemiarthroplasty for hallux rigidus. Operative Techniques in Orthopaedics 1999;9(1):33
  10. Townley, MD, Taranow, DO. A metallic hemiarthroplasty resurfacing prosthesis for the hallux metatarsophalangeal joint. Foot & Ankle International 1994;15(11):575-80 (View Study)
  11. Christine C. Salonga, DPM, David C. Novicki, DPM, FACFAS , Martin M. Pressman, DPM, FACFAS , D. Scot Malay, DPM, MSCE, FACFAS. A Retrospective Cohort Study of the BioPro Hemiarthroplasty Prosthesis. The Journal of Foot & Ankle Surgery 49 (2010) 331–339 9 (View Study)
  12.  Giza, E., Sullivan, M., Ocel, D., Lundeen, G., Mitchell, M., & Frizzell, L. (2010). First metatarsophalangeal hemiarthroplasty for hallux rigidus. International Orthopaedics, 34(8), 1193–1198. https://doi.org/10.1007/s00264-010-1012-x 13. Garras, D. N., Durinka, J. B., Bercik, M., Miller, A. G., & Raikin, S. M. (2013). Conversion Arthrodesis for Failed First Metatarsophalangeal Joint Hemiarthroplasty. Foot & Ankle International, 34(9), 1227–1232. (View Study)
  13. Jacob HA. Forces acting in the forefoot during normal gait–an estimate. Clin Biomech (Bristol, Avon). 2001 Nov;16(9):783-92. doi: 10.1016/s0268-0033(01)00070-5. PMID: 11714556.
  14. Garras, D. N., Durinka, J. B., Bercik, M., Miller, A. G., & Raikin, S. M. (2013). Conversion Arthrodesis for Failed First Metatarsophalangeal Joint Hemiarthroplasty. Foot & Ankle International, 34(9), 1227–1232.
  15. Gheorghiu D, Coles C, Ballester J. Hemiarthroplasty for Hallux Rigidus: Mid-Term Results. J Foot Ankle Surg. 2015 Jul-Aug;54(4):591-3. doi: 10.1053/j.jfas.2014.11.001. Epub 2015 Mar 4. PMID: 25746772.
  16. Adair CR, Zide JR, Royer CT, Reddy V, Brodsky JW. Short Term Radiographic Analysis of the Cartiva Implant for Hallux Rigidus. Foot & Ankle Orthopaedics. October 2019. doi:10.1177/2473011419S00086