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Joint distraction (KJD) in treatment of knee osteoarthritis: cartilage changes in a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

Joint distraction (KJD) in treatment of knee osteoarthritis: cartilage changes in a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO) - Joint distraction versus osteotomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39482
Enrollment
69
Registered
2011-04-28
Start date
2011-06-16
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

joint degeneration osteoarthritis

Interventions

HTO is performed according to regular clinical practice. KJD is performed according to a standard protocol. An external fixator bridging the joint by use of two Stryker monotubes is placed. Intra-op

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with medial or lateral tibio-femoral compartmental OA considered for HTO according to regular clinical practice, Age

Exclusion criteria

Exclusion criteria: Mechanic axis-deviation of less than 10 degrees Psychological inabilities or difficult to instruct Not able to undergo MRI examination according to standard checklists Inflammatory or rheumatoid arthritis present or in history Post traumatic fibrosis due to fracture of the tibial plateau Bone-to-bone contact in the joint (absence of any joint space on X-ray) Surgical treatment of the involved knee

Design outcomes

Primary

MeasureTime frame
- Cartilage changes determined by decrease in area of denuded bone using quantitative MRI analyses (according to Eckstein) at 2 years (blinded evaluation).

Secondary

MeasureTime frame
- Cartilage changes determined by X-rays (joint space width using KIDA), additional quantitative MRI parameters (Eckstein), and biochemical markers analyses (blinded evaluation). - Clinical efficacy over time by self assessed questionnaire (KOOS score for pain, other symptoms, function in daily living, function in sports and recreation, and knee related quality of life) and VAS for pain (non-blinded). - Medical consumption and non-medical costs related to disease and treatment are estimated by a questionnaire (custom made). Quality of life is evaluated by questionnaires (EQ-5D) (non-blinded).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)