Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis

Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis - Knee joint distraction compared to total knee prosthesis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39144

Enrollment

Registered

2010-12-28

Start date

2011-03-09

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

joint degeneration osteoarthritis

Interventions

KJD is performed according to the methodology as used in previous knee distraction studies, using 2 monotubes, one laterally and one medially. Intra-operative the tubes are distracted 2 mm. During h

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients considered for TKP according to regular clinical practice Age

Exclusion criteria

Exclusion criteria: 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

Measure	Time frame
1. Clinical effectiveness determined by WOMAC.	—

Secondary

Measure	Time frame
2. Clinical effectiveness determined by KOOS. 3. Pain evaluated with VAS score. 4. Indication of costs-effectiveness. 5. Structural repair of cartilage as detemined on X-rays, MRI and biomarker analysis (only in patients treated with KJD) in comparison with own baseline values.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)