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Foot & AnkleRCT

To Walk or Not? A Prospective, Randomised Controlled Trial to Evaluate the Effect of Weightbearing on Patient Outcomes Following First Metatarsophalangeal Joint Fusion

Foot & Ankle International · 9 Oct 2026

Rigour40/100
Clinical45/100
Impact†48/100

† Impact is the editorial-priority score. All scores are out of 100. Clinical is a stored clinical-importance score from the earlier method; it has not been recalculated.

Why it matters

First MTP fusion is the standard operation for end-stage hallux rigidus, and whether patients must stay off the foot for 6 weeks has a large effect on driving, work, falls risk and who can safely be offered surgery.

The evidence

This randomised trial compared walking on the foot right away (weightbearing as tolerated in a stiff postoperative shoe) with 6 weeks of strict non-weightbearing in a cast after first metatarsophalangeal (big toe) joint fusion in 68 adults with hallux rigidus. At 12 months, pain and function improved similarly in both groups. FAAM-ADL function was 3.71 points lower with immediate weightbearing (95% CI -12.21 to 4.79), VAS pain was 0.43 points higher (95% CI -0.63 to 1.49), and there were no nonunions and one hardware removal in each group.

A coherent primary effect estimate is unavailable. Clinical relevance does not estimate treatment benefit.

Why this rigour score?

Multicentre RCTDesign starting point: 63.4

40/ 100

Raised the score

  • Adequately powered+6
  • Concealed allocation+5.1

Lowered the score

    No negative adjustments recorded.

    Score capped at 40. The conclusions are not supported by the reported results.

    Methods at a glance

    Recorded assessment
    • Outcome assessors blindedNot reported
    • Allocation concealedMet
    • Random sequence generatedMet
    • Intention-to-treat analysisNot reported
    • Adequate statistical powerMet
    • Prospective registrationMet

    Not reported does not mean not done. Checks have different weights; this is not a count of boxes ticked.

    See the full score breakdown
    Study design starting point
    63.4
    Concealed allocation
    +5.1
    Random sequence generation
    +2.5
    Compared against current standard of care
    +3.4
    Adequately powered
    +6
    Prospectively registered
    +5.1
    Methodological cap
    −45.5
    Final rigour score rounded
    40 / 100

    Study design sets the starting point and a ceiling of 100. Recorded methods then adjust the score. Points are shown to one decimal place; the final score uses unrounded values.

    Checklist from the stored appraisal. “Not met” describes the recorded criterion; it does not always produce a deduction. This overview supports reading the full study.

    For journal club

    1.If immediate weightbearing gives similar pain relief but a meaningful functional disadvantage cannot be ruled out, how would you counsel a patient choosing between a cast with crutches and walking in a postoperative shoe after big toe fusion?

    2.Which patients (for example those with diabetes, osteoporosis, inflammatory arthritis or large deformity) would you still keep non-weightbearing after first MTP fusion, and how might your choice of screws versus a plate influence that decision?

    Original publication title

    To Walk or Not? A Prospective, Randomised Controlled Trial to Evaluate the Effect of Weightbearing on Patient Outcomes Following First Metatarsophalangeal Joint Fusion

    Read original paper