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

NCT05992038 | Recruiting

• 1 other identifier: 84534
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 postoperative phase. This is probably due to a combination of bony cut (bone pain) and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to potentially reduce postoperative pain by reducing the bleeding from the bone gap. Objective: The main aim of this study is to determine whether early postoperative pain is decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open wedge osteotomy without filling the gap. The secondary aims are faster accelerated rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and the occurrence of (serious) adverse events. Study design: Single-blinded, prospective, randomized controlled trial. Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double level osteotomy. Intervention: According to a randomization scheme, the osteotomy gap will be filled with either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional method). Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS) pain during the first week postoperative. The secondary study endpoints are faster rehabilitation/regaining function, reduction of local blood loss, accelerated bone union, comparable surgical accuracy, and (serious) adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients may have the advantage of experiencing less pain postoperatively if they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation. Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone fusion and excessive bone growth. However, the preclinical studies and clinical studies show that the use of AttraX® Putty is safe for use in humans.

Conditions

Osteo Arthritis Knee

Keywords

Osteotomy; Gap filler; Postoperative pain; Randomized controlled trial; AttraX Putty

Outcome Measures

Primary Outcomes (1)

• The mean NRS pain score

  Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.

  First week postoperative daily score

Secondary Outcomes (5)

• Rehabilitation time

  After surgery (+2 weeks, +1 months, +3 months, +6 months, +1 year)

• Reduction of local blood loss

  Before surgery and 1 day after surgery

• Reduction of local blood loss

  Before surgery and a weekly home measurement up to and including 1 month after surgery.

• Union rate

  +1 months, +4 months, +6months, and +12 months

• Postoperative NRS pain score

  After surgery (second week daily score), +1 months, +3months

Study Arms (2)

Putty

EXPERIMENTAL

The osteotomy gap will be filled with a synthetic ceramic material, Putty

Procedure: Osteotomy with putty

Conventional

PLACEBO COMPARATOR

Osteotomy performed according to the conventional method, without gap filler

Procedure: Conventional osteotomy

Interventions

Osteotomy with putty PROCEDURE

Synthetic ceramic putty

Putty

Conventional osteotomy PROCEDURE

conventional osteotomy

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University medical center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

RECRUITING

Related Links

• Structural allograft impaction enables fast rehabilitation in opening-wedge high tibial osteotomy: a consecutive case series with one year follow-up
• Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting
• Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Osteotomy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• R.J.H. Custers, Dr

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

R.J.H. Custers, Dr

CONTACT

088 7558327; r.j.h.custers@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 15, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)