Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04677907

Health Economic and Clinical Comparison of Trabecular Metal Uncemented and Cemented Modular Total Knee Replacements - A Double Blinded Randomised Controlled Trial

Led by NHS Greater Glasgow and Clyde · Updated on 2025-06-25

144

Participants Needed

1

Research Sites

499 weeks

Total Duration

On this page

Sponsors

N

NHS Greater Glasgow and Clyde

Lead Sponsor

Z

Zimmer Biomet

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the differences in clinical outcomes, patient satisfaction, and survivorship between cemented and uncemented total knee replacements (TKR). The study aims to determine if there are health economic benefits to using uncemented TKRs within the NHS. This randomized controlled trial compares these two types of knee prostheses over a 10-year period to understand their impact on patients with knee osteoarthritis. Participants will receive either a cemented modular knee replacement, which is the current standard, or an uncemented modular knee replacement made of trabecular metal. The study will use clinical knee scores including the New Knee Society Score, Oxford Knee Score, and Forgotten Joint Score to assess knee function and patient awareness of their artificial joint. Movement analysis using Inertial Measuring Units will measure functional improvements in daily tasks before and after surgery. The study also includes a health economic assessment focusing on operation time and resource utilization. Participants will be followed for 10 years with periodic clinical evaluations, radiological assessments, and patient-reported outcome measures such as pain, function, satisfaction, anxiety, depression, and quality of life. Data will be collected at baseline, 3 months, 1, 2, 5, and 10 years post-operatively. The study will monitor complications, functional recovery, and overall health economic impact. Patient adherence and follow-up attendance are important components of the study protocol.

CONDITIONS

Brief Title

TRabecular Metal Economic and Clinical Knee Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects may be recruited to the evaluation.
  • There are no age restrictions for participation.
  • Subjects must be able to give voluntary, written informed consent.
  • Subjects must be able to understand the study, cooperate with procedures, and attend all post-operative follow-ups.
  • Subjects with uni-lateral osteoarthritis of the knee or bi-lateral osteoarthritis with a well-functioning, pain-free knee replacement in the other knee.
  • Subjects who require a total knee replacement for surgical management of osteoarthritis.
Not Eligible

You will not qualify if you...

  • Patients with conditions that would compromise their participation or follow-up in the study.
  • Patients with bi-lateral disease significantly impacting current function and pain.
  • Patients requiring revision knee arthroplasty surgery.
  • Patients with disorders of the feet, ankles, hips, or spine causing abnormal gait or significant pain.
  • Patients with neurological conditions affecting movement.
  • Patients with pathology expected to adversely affect healing.
  • Patients with disorders likely to impair rehabilitation.
  • Subjects unlikely to comply with the study follow-up protocol.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo total knee replacement surgery with either a cemented or uncemented modular knee prosthesis.

1 visit (in-person)

Post-operative Follow-up

Duration - Up to 10 years post-operatively

Participants are followed for clinical and radiological assessments to monitor knee function, complications, and recovery after surgery.

Visits at 3 months, 1 year, 2 years, 5 years, and 10 years post-operatively

Trial Site Locations

Total: 1 location

1

Dept of Orthopaedics, Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom, G31 2ER

Actively Recruiting

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Research Team

M

Mark JG Blyth, Mr

J

James Doonan, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

A trabecular metal tibial component in total knee replacement in patients younger than 60 years: a two-year radiostereophotogrammetric analysis.

A Henricson, L Linder, K G Nilsson

https://pubmed.ncbi.nlm.nih.gov/19043129

Evaluation of micromotion in cemented vs uncemented knee arthroplasty in osteoarthrosis and rheumatoid arthritis. Randomized study using roentgen stereophotogrammetric analysis.

K G Nilsson, J Kärrholm, L Ekelund...

https://pubmed.ncbi.nlm.nih.gov/1940933

The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales.

P N Baker, J H van der Meulen, J Lewsey...

https://pubmed.ncbi.nlm.nih.gov/17673581