Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty: A Randomized Controlled Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03530839

Enrollment

Registered

2018-05-21

Start date

2015-01-31

Completion date

2017-05-31

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Claw Toe, Lesser Toe Deformity

Keywords

lesser toe deformity, claw toe, PIP joint, arthrodesis, resection arthroplasty

Brief summary

Background: The aim of this study was to compare operative outcomes after lesser toe deformity correction with either proximal interphalangeal (PIP) joint arthrodesis or PIP joint resection arthroplasty. Methods: A prospective randomized controlled trial was performed on 37 patients (48 toes) who underwent one of these two procedures. The Numeric Rating Scale (NRS) for pain, American Orthopaedic Foot and Ankle Society (AOFAS) score, osseous consolidation, and clinical outcome were evaluated preoperatively and at 6 weeks and 6 months postoperatively.

Interventions

PROCEDUREArthrodesis

see study group description

PROCEDUREResection arthroplasty

see study group description

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with one or more claw toes with rigid PIP joint flexion and extension deformity of the MTP joint scheduled for surgical intervention in the investigator's department

Exclusion criteria

* known osteoporosis or other bone metabolism disorders * prior surgery on the toe scheduled for the intervention * immunodeficiency or immunosuppressive drug intake * pregnancy * non-palpable pulses of the posterior tibial artery or the dorsalis pedis artery * anticoagulation therapy with the exception of acetylsalicylic acid * a lack of sufficient physical resilience to allow free self-mobilization and walking.

Design outcomes

Primary

Measure	Time frame	Description
Pain	Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively	Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))
Function	Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively	Change in function was evaluated using the American Orthopaedic Foot and Ankle Society score (ranging from 0 (severe impairment) to 100 (no problems with foot))

Secondary

Measure	Time frame	Description
Osseous consolidation	6months postoperatively	Osseous consolidation of the procedure was evaluated using x-rays

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026