CClinicalTrials.gg
Sign In
CompletedNCT03530839Updated May 21, 2018

Lesser Toe PIP Joint Arthrodesis Versus Resection Arthroplasty

An interventional study of Arthrodesis and Resection arthroplasty in Claw Toe and Lesser Toe Deformity, sponsored by University Hospital Tuebingen. Completed. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2015, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Claw Toe
  • Lesser Toe Deformity

Keywords

  • lesser toe deformity
  • claw toe
  • PIP joint
  • arthrodesis
  • resection arthroplasty
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 37 is below the median of 49 across 491 interventional studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Arthrodesis

    Arthrodesis of the proximal interphalangeal joint by using a threaded K-wire

    Procedure: Arthrodesis

  • Active comparator
    Resection arthroplasty

    Resection arthroplasty of the proximal interphalangeal joint using a normal K-wire

    Procedure: Resection arthroplasty

Interventions

  • ProcedureArthrodesis

    see study group description

  • ProcedureResection arthroplasty

    see study group description

06

What researchers measure

Primary outcomes

  1. Pain

    Change in pain was evaluated using the Numeric Rating Scale for pain (ranging from 0 (no pain) to 10 (maximum pain))

    Time frame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively

  2. Function

    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))

    Time frame: Change from preoperatively to 6 weeks postoperatively and to 6months postoperatively

Secondary outcomes

  1. Osseous consolidation

    Osseous consolidation of the procedure was evaluated using x-rays

    Time frame: 6months postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03530839
Lead sponsor
University Hospital Tuebingen
Responsible party
Dr. Ulf Krister Hofmann (Senior physician, University Hospital Tuebingen) — Principal investigator
First posted
May 21, 2018
Start date
Jan 2015
Primary completion
May 2017
Completion
May 2017
Last update
May 21, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hammer Toe Syndrome

Other studies from this sponsor

University Hospital Tuebingen

Start the discussion