Clinical and radiological evaluation of Signature* unicompartmental knee arthroplasty A Prospective, Multi-centre, Randomized, Double blind study

Clinical and radiological evaluation of Signature* unicompartmental knee arthroplasty A Prospective, Multi-centre, Randomized, Double blind study - Evaluation of Signature for unicompartmental knee arthroplasty

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37439

Enrollment

120

Registered

2012-11-06

Start date

2015-04-21

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

joint wear osteoarthritis of the medial knee compartment

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Painfull and disabled knee joint resulting from osteoarthritis of the medial knee compartment. •High need to obtain pain relief and improve function, -Above 18 years old (full skeletal maturity). -Body-mass-index (BMI)

Exclusion criteria

Exclusion criteria: -Patients with osteoarthritis of more than only the medial knee compartment -Active infection in knee -General infection -Distant foci of infections which may spread to the implant site -Failure of previous joint replacement -Pregnancy -Previous major knee surgery, except for arthroscopic meniscectomy. -Metal near knee joint (MRI-scan not possible) -Not able or willing to undergo MRI-scan and CT-scan -Reumatoid arthritis -Extension deficit of more than 15 degrees -Flexion less than 110 degrees -Non-correctable varus axis -Cruciate ligament insufficiency

Design outcomes

Primary

Measure	Time frame
-Oxford knee score at 1 Year. -Alignment of the femoral and tibial prosthesis 6 W in the frontal plane.	—

Secondary

Measure	Time frame
-Questionnaires o American Knee Society Score, WOMAC, Oxford Knee - 12, EQ-5D, VAS: at 3 months, 1 year, 2 years, 5 years and 10 years. -Efficacy o Operation time o Length of hospital stay o Fit, form and practical use of the Signature* alignment guides. -Safety o Adverse events/complications: Intra-operative, post-operative during trial o Needed change of plans per-operative: change of size of prosthesis, conversion Signature procedure to conventional procedure for any reason -Survivorship at 10 years post-operative -Cost-effectiveness o All material costs of both procedures -Shape-matching o Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. o Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. o Difference in thickness of the in vivo inserted polyethylene compared to pre-operatively calculated thickness of this insert.	—

Measure

Time frame

-Questionnaires o American Knee Society Score, WOMAC, Oxford Knee - 12, EQ-5D, VAS: at 3 months, 1 year, 2 years, 5 years and 10 years. -Efficacy o Operation time o Length of hospital stay o Fit, form and practical use of the Signature* alignment guides. -Safety o Adverse events/complications: Intra-operative, post-operative during trial o Needed change of plans per-operative: change of size of prosthesis, conversion Signature procedure to conventional procedure for any reason -Survivorship at 10 years post-operative -Cost-effectiveness o All material costs of both procedures -Shape-matching o Occurrence (and percentage) of outliers in alignment in the frontal, sagittal and horizontal plane of femoral and tibial components. o Occurrence (and percentage) of outliers in alignment of the mechanical axis of the leg. o Difference in thickness of the in vivo inserted polyethylene compared to pre-operatively calculated thickness of this insert.

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Countries

Netherlands

Outcome results