NCT06134050

Brief Summary

The purpose of this RCT is to investigate whether high tibial osteotomy using 3D printed patient specific guides aiming at 55% correction is non-inferior to aiming at 62%.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
29mo left

Started Nov 2023

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Nov 2023Oct 2028

First Submitted

Initial submission to the registry

June 23, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

June 23, 2023

Last Update Submit

November 10, 2023

Conditions

Osteoarthritis, KneeKnee Pain ChronicArthralgia

Keywords

osteotomykneeosteoarthritis3D printPSIHigh tibial osteotomyKnee overloadInertial measurement unitsIMUwearable sensorsgait analysisaccelerometer

Outcome Measures

Primary Outcomes (1)

  • Knee injury and Osteoarthritis Outcome Score subscore Quality of Life (KOOS QOL), 0-100, 100 best score

    Knee related Quality of Life

    24 months

Secondary Outcomes (5)

  • Knee injury and Osteoarthritis Outcome Score 12 Short form (KOOS-12), 0-100, 100 best score

    24 months

  • Forgotten Joint Score-12(FJS-12), 0-100, 100 best score

    24 months

  • EuroQol-5D (EQ-5D), index 0-1, 1 best score

    24 months

  • University of California at Los Angeles activity level (UCLA), 0-10, 10 most active

    24 months

  • Ground contact time (milliseconds)

    24 months

Other Outcomes (1)

  • HKA X-ray measures (Standing Hip-Knee-Ankle x-ray)

    6 months

Study Arms (2)

55% correction

EXPERIMENTAL

HTO using PSI targeted at 55% correction axis

Procedure: Procedure: HTO using PSI aiming at 55% correction

62% correction

ACTIVE COMPARATOR

HTO using PSI targeted at 62% correction axis

Procedure: Procedure: HTO using PSI aiming at 62% correction

Interventions

Procedure: HTO using PSI aiming at 55% correctionPROCEDURE

HTO using PSI designed to achieve correction to 55% tibial width.

55% correction
Procedure: HTO using PSI aiming at 62% correctionPROCEDURE

HTO using PSI designed to achieve correction to 62% tibial width.

62% correction

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having accepted and signed the informed consent form before surgery
  • Patients aged 30-60 years
  • Patients with an indication for primary HTO based on anamnestic, clinical and radiological findings leading to the diagnosis of major medial knee compartment overload symptoms
  • Mechanical varus axis of 3-9 deg. (calculated on full length weightbearing X-ray (FLWB))
  • Correctable angular deformity on the tibia only (medial proximal tibial angle (MPTA) + planned correction \< 95 deg. Lateral distal femoral angle (LDFA) \<92 deg.)
  • Maximal calculated gap height 14 mm
  • Only the first knee will be included if later contralateral HTO

You may not qualify if:

  • Inflammatory arthritis (Rheumatoid Arthritis, Bechterew arthritis, Psoriatic Arthritis)
  • Patients using Prednisolone perorally
  • Smokers (need to quit preoperatively)
  • Significant overweight (Body Mass Index \> 35)
  • Earlier fractures in affected leg with fracture malalignment \>5 deg.
  • Extension deficit \>10 deg. in the affected knee
  • Earlier septic arthritis/osteomyelitis in the affected leg
  • Previous major surgery affecting leg function. Earlier knee arthroscopic procedures like ACL-reconstruction are not excluded
  • Planned combined procedures involving HTO + ACL/PCL-reconstruction, meniscal transplantation or meniscal root fixation is excluded
  • Neurologic disease with symptoms affecting the leg
  • Serious illness or other factors that make communication, follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease, non-Norwegian speakers).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeArthralgiaOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tor Kjetil Nerhus, MD, PhD

    Martina Hansens Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geir Solberg, MD

CONTACT

+4746821397geir.solberg@mhh.no

Tor Kjetil Nerhus, MD,PhD

CONTACT

+4793409934kjetil.nerhus@mhh.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants blinded. Care provider/surgeon not possible to mask. Investigator masked. Outcome assessor masked/blinded data set.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

November 18, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2028

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share