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

Trial Summary

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.

Is weightbearing generally safe for humans?

The research does not provide specific safety data on weightbearing for hallux rigidus, but it does mention potential complications with related treatments, such as implant subsidence and infection in Cartiva hemiarthroplasty, and skin complications with Swanson Silastic implants. These findings suggest that while weightbearing itself is not directly evaluated, related treatments can have safety concerns. ^{1 2 3 4 5}

How does the weightbearing treatment for hallux rigidus differ from other treatments?

Weightbearing treatment for hallux rigidus is unique because it focuses on allowing the patient to bear weight on the affected foot, which can help maintain joint function and mobility. This contrasts with surgical options like arthrodesis, which eliminate joint motion, or arthroplasty, which aims to preserve motion but involves more invasive procedures. ^{6 7 8 9 10}

What is the purpose of this trial?

randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions

Research Team

Mark Glazebrook, MD FRCS

Principal Investigator

NSHA\ Dalhousie UNiversity

Eligibility Criteria

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.

I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

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

Unable to comply with follow up schedule and requirements

I am under 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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 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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Nonoperative Management of Hallux Limitus Using a Novel Forefoot Orthosis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Radiographic changes in forefoot geometry with weightbearing. [2017]

5. Belgium 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]. [2016]

6. Scotland pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

The modified oblique keller capsular interpositional arthroplasty for hallux rigidus. [2022]

8. France 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of advanced hallux rigidus by interpositional arthroplasty. [2014]

10. United States pubmed.ncbi.nlm.nih.gov

Prevalence of Hallux Rigidus in Patients With End-Stage Ankle Arthritis. [2021]