Weightbearing for Hallux Rigidus

Overseen By Patricia Francis, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Age <18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how weightbearing influences recovery after surgery to fuse the big toe joint, often necessary for individuals with hallux rigidus (a stiff big toe). Researchers will compare two groups: one will begin walking immediately after surgery, while the other will avoid weightbearing on the foot for six weeks. Eligible participants are those who have tried other treatments, such as special shoes or pain medication, without success and require surgery to fuse only the big toe joint. As an unphased trial, this study provides a unique opportunity to enhance understanding of recovery methods following toe joint fusion surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that weightbearing is safe for first MTP joint fusions?

Research has shown that after surgery for hallux rigidus (a stiff big toe), putting weight on the foot can cause some pain, especially on the side of the foot. This occurs because individuals try to avoid putting pressure on the big toe. Although specific safety data on weight-bearing is lacking, studies indicate that people might experience discomfort due to altered walking patterns to protect the toe.

No clear evidence links weight-bearing to serious problems. Those considering this treatment should discuss any concerns with their healthcare provider. This discussion helps them understand what to expect and how to manage any discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Weightbearing for Hallux Rigidus trial because it explores a more immediate return to weightbearing after surgery for hallux rigidus, a condition that typically involves a lengthy non-weightbearing recovery period. Traditionally, patients have to avoid putting weight on the foot for about six weeks post-surgery, which can be inconvenient and limit mobility. This trial is investigating whether allowing patients to bear weight right after surgery can lead to quicker recovery and improved outcomes. If successful, this approach could make the post-surgical process more comfortable and less disruptive for patients.

What evidence suggests that weightbearing is effective for hallux rigidus?

This trial will compare immediate weightbearing with non-weightbearing for patients after surgery for hallux rigidus. Research has shown that walking with weight on the foot after surgery for a stiff big toe joint, known as hallux rigidus, can be beneficial. One study found that a special shoe insert improved foot function and reduced pain in 94.7% of patients with a similar condition called hallux limitus. Another study examined various methods to stabilize the toe and allow weight-bearing after surgery, finding them effective in enhancing recovery. These findings suggest that walking with weight on the foot might aid in recovery and reduce pain for those undergoing surgery to fuse the big toe joint. ^{1 2 3 6 7}

Who Is on the Research Team?

Mark Glazebrook, MD FRCS

Principal Investigator

NSHA\ Dalhousie UNiversity

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need surgery for a stiff or painful big toe joint, often due to bunions or arthritis. They should have tried other treatments like orthotics and painkillers without success. Participants must be healthy enough for surgery and willing to follow the study's check-up schedule.

Inclusion Criteria

I am healthy enough to undergo surgery.

I am having surgery to fuse my big toe joint.

Able and willing to comply with follow up schedule and requirements

Exclusion Criteria

Unable to comply with follow up schedule and requirements

My surgery involves more than just fusing the big toe joint.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 1st MTP joint fusion surgery with either immediate weight bearing or non-weight bearing for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of pain and function

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Weightbearing

Trial Overview The study is testing whether putting weight on your foot soon after big toe joint fusion surgery affects recovery. It's a randomized-controlled trial, meaning patients are randomly assigned to start weight bearing at different times post-surgery.

How Is the Trial Designed?

Group I: Weightbearing Active Control 1 Intervention

Immediate weightbearing after surgery

Group II: Non weightbearing Active Control 1 Intervention

nonweightbearing x 6 weeks post surgery

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 25 patients with advanced hallux rigidus, modified interpositional arthroplasty resulted in a high mean postoperative AOFAS score of 93.6, indicating effective pain relief and improved function after at least 15 months of follow-up.

75% of patients reported complete satisfaction with their surgical outcomes, suggesting that this technique is a promising alternative to arthrodesis, which typically results in loss of mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of advanced hallux rigidus by interpositional arthroplasty. Sanhudo, JA., Gomes, JE., Rodrigo, MK.[2014]

In a clinical study of patients who underwent surgery for severe hallux valgus using the Swanson-total great toe hinged prosthesis, it was found that inadequate weight-bearing by the great toe led to excessive pressure on the lesser metatarsals, causing complications like keratomas and metatarsalgia.

The study suggests that the Swanson-total prosthesis primarily acts as a joint spacer for pain relief rather than restoring normal function, indicating that adjustments such as shortening osteotomies of the lesser metatarsals may be necessary to improve weight distribution and reduce postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical evaluation of the total first metatarsophalangeal joint prosthesis: the use of footprints in assessing foot contact. Arenson, DJ., Proner, SC.[2009]

In a study of 99 patients, weightbearing conditions significantly increased intermetatarsal angles in forefoot geometry, indicating that weightbearing affects the measurements taken during radiographs.

Hallux valgus angles were larger in non-weightbearing conditions, suggesting that radiological assessments of forefoot geometry must be consistent in weightbearing status to ensure accurate evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiographic changes in forefoot geometry with weightbearing. Fuhrmann, RA., Layher, F., Wetzel, WD.[2017]

The modified oblique Keller capsular interpositional arthroplasty provides better clinical outcomes and greater range of motion compared to first metatarsophalangeal joint arthrodesis, as shown in a study of 10 patients undergoing arthroplasty versus 12 patients undergoing arthrodesis.

Patients who had the arthroplasty experienced a more normal pattern of plantar pressures during walking, indicating that this motion-sparing procedure may offer functional advantages over the traditional arthrodesis approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The modified oblique keller capsular interpositional arthroplasty for hallux rigidus. Mackey, RB., Thomson, AB., Kwon, O., et al.[2022]

A retrospective study of 28 patients with moderate hallux rigidus showed that a new surgical technique significantly improved pain levels, with the American Orthopedic Foot and Ankle Society (AOFAS) score increasing from an average of 59 to 84 after 4 years.

The surgical method, which preserves the native joint, did not significantly change the range of motion (ROM) postoperatively, indicating that it effectively alleviates pain while maintaining joint function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous arthroscopically assisted cheilectomy combined to percutaneous proximal phalanx osteotomy in hallux rigidus: Clinical and radiological outcomes in 30 feet at a 48-month follow-up. Di Nallo, M., Lebecque, J., Lucas Y Hernandez, J., et al.[2023]

A novel forefoot orthosis significantly improved foot function and reduced pain in 19 patients with symptomatic hallux limitus over a 4-week period, with 94.7% of participants reporting benefits and 63.2% achieving complete pain resolution.

The orthosis allowed for better weight distribution on the affected joint without requiring changes to footwear or affecting normal walking, making it a promising alternative for patients who are dissatisfied with current treatments or are not candidates for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonoperative Management of Hallux Limitus Using a Novel Forefoot Orthosis. Fung, J., Sherman, A., Stachura, S., et al.[2021]

A systematic review of gait studies comparing total arthroplasty and arthrodesis for end-stage hallux rigidus found significant heterogeneity in the available research, making it difficult to draw clear conclusions about the differences in gait outcomes between the two surgical options.

Only one randomized controlled trial was identified, and while some studies suggested that total arthroplasty may preserve dynamic motion at the first metatarsophalangeal joint, overall findings were inconsistent, highlighting the need for more rigorous and standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of total arthroplasty and arthrodesis for end-stage hallux rigidus: A biomechanical perspective. Rajan, R., Mishra, A.[2021]

In a study of 870 feet from 809 patients with end-stage ankle arthritis, the prevalence of radiographic hallux rigidus (HR) was found to be 72.9%, which is significantly higher than in the general population.

The study also revealed that the prevalence of HR increases with age, and it was slightly higher in patients with inflammatory and primary arthritis, indicating a potential link between these conditions and the development of HR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of Hallux Rigidus in Patients With End-Stage Ankle Arthritis. Bejarano-Pineda, L., Cody, EA., Nunley, JA.[2021]

A review of the FDA's MAUDE database revealed 49 reported complications related to the Cartiva synthetic cartilage implant, with implant subsidence being the most common issue, occurring in 16 cases.

The analysis highlighted that many complications, such as fragmentation and infection, are underreported in the literature, suggesting a need for improved reporting mechanisms to better understand the true incidence of these device-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Related to Cartiva Hemiarthroplasty of First Metatarsal: An Analysis of Reports to the United States Food and Drug Administration. Metikala, S., Mahmoud, K., O'Connor, KM., et al.[2022]

In a review of 28 cases of hallux rigidus treated with Swanson Silastic implants over 8 years, long-term patient satisfaction was reported to be good despite a significant rate of skin complications.

Radiologic findings indicated that the implants wear out quickly on the articular side and can cause granulomatous reactions around the stems, leading to altered weight distribution on the foot.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The treatment of rigid hallux using Swanson's silastic implant (single and double stem). Clinical, radiological and podobarographic review with a 16-year maximum follow-up]. Mahieu, C., Chaput, A., Bouillet, R.[2016]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S126877312500219X

An Evidenced Based Review of the Efficacy of Fixation ... This study aimed to review and assess the quality of literature supporting the efficacy of fixation methods and postoperative weight-bearing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10369095/

Republication of “Current Concepts Review: Hallux Rigidus” A prospective study of 75 feet treated with a Keller resection arthroplasty found pain relief in 91% of patients but a cock-up toe deformity in 41% of patients ...

3. withpower.com withpower.com/trial/phase-hallux-valgus-8-2020-60c92

Weightbearing for Hallux Rigidus A novel forefoot orthosis significantly improved foot function and reduced pain in 19 patients with symptomatic hallux limitus over a 4-week period, with 94.7% ...

4. bmjopen.bmj.com bmjopen.bmj.com/content/bmjopen/11/8/e049298.full.pdf

Treatment of hallux rigidus (HARD trial): study protocol of a ... After the initial randomisation visit, all patients are further eval- uated by weight- bearing CT (WBCT). Primary and secondary outcome measures.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03935880

NCT03935880 | Surgical Treatment for Great Toe Arthritis Both procedures have shown to have beneficial results in patients with grade 2 hallux rigidus, yet it is unclear if one procedure would be preferred in this ...

6. nhslanarkshire.scot.nhs.uk nhslanarkshire.scot.nhs.uk/services/podiatry/hallux-limitus-rigidus/

Hallux Limitus/Rigidus (Osteoarthritis) - NHS Lanarkshire Pain, usually at the top of your big toe joint that worsens with weight bearing activity; Difficulty bending your big toe; A bony lump/ soft tissue swelling ...

7. physio-pedia.com physio-pedia.com/Hallux_Rigidus

Hallux Rigidus Weight-bearing, anterior-posterior and lateral radiographs are usually needed to examine the joint. Often, non-uniform joint space narrowing, and widening or ...