Status:

RECRUITING

Use of a Putty as Gap Filler in Open-wedge Osteotomy

Lead Sponsor:

UMC Utrecht

Conditions:

Osteo Arthritis Knee

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperati...

Detailed Description

Rationale: Realignment osteotomies around the knee are a proven surgical treatment for unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in the early postoperati...

Eligibility Criteria

Inclusion

  • indication for an open-wedge osteotomy of the femur, tibia or double level due to unicompartmental osteoarthritis (OA).
  • Comply with all aspects of the treatment, including CT scans, radiographs and 1-year follow-up
  • Informed consent

Exclusion

  • Osteotomy for indication of cartilage treatment or other knee surgeries than unicompartmental OA
  • Correction using an open wedge above 10 mm
  • Pregnant women at time of enrollment or women who are planning to become pregnant during the duration of the study

Key Trial Info

Start Date :

September 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05992038

Start Date

September 20 2023

End Date

December 1 2026

Last Update

September 21 2023

Active Locations (1)

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1

University medical center Utrecht

Utrecht, Netherlands, 3584 CX