Patient Specific Instrumentation in TKR

NCT02096393 | Completed

• 1 other identifier: STH16313
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Implant alignment

  Sagittal and coronal alignment of the knee arthroplasty implant will be measured on full length radiographs

  6 weeks

Secondary Outcomes (1)

• Oxford Knee Score

  1yr, 5yr, 10yr

Other Outcomes (2)

• EUROQOL-5D

  1 year, 5 years and 10 years

• IKKS Score

  1yr, 5 yr, 10yr

Study Arms (2)

Patient specific instrumentation

EXPERIMENTAL

The patient will undergo using patient specific instrumentation

Device: Zimmer Patient specific instruments

Standard instrumentation

ACTIVE COMPARATOR

The patient will undergo surgery using standard instrumentation

Device: Standard instrumentation

Interventions

Zimmer Patient specific instruments DEVICE

A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.

Patient specific instrumentation

Standard instrumentation DEVICE

Standard instrumentation will be used during total knee replacement surgery.

Standard instrumentation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18-75 years at time of surgery.
• Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
• Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
• Patients who signed the study consent form prior to surgery.

You may not qualify if:

• Pregnant women.
• Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
• Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
• Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
• Muscle contracture around the knee joint
• Individuals with active or suspected infection or sepsis.
• Patients with contraindication to MRI

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (2)

Rotherham District General Hospitals NHS Trust

Rotherham, South Yorkshire, S60 2UD, United Kingdom

Location

Sheffield Teaching Hospital NHS Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Caroline Blakey, MBChB

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2014
• First Posted: March 26, 2014
• Study Start: September 1, 2013
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

GB (2)