Patient Specific Instrumentation in TKR

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02096393
• Collaborator: (none)
• Enrollment: 72
• Locations: 2
• Arms: 2
• Actual Duration (Months): 81.5
• Patients Per Site: 36
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Device: Zimmer Patient specific instruments; Device: Standard instrumentation	N/A

Detailed Description

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 process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation In Total Knee Arthroplasty
• Actual Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jun 18, 2020
• Actual Study Completion Date: Jun 18, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient specific instrumentation The patient will undergo using patient specific instrumentation	Device: Zimmer Patient specific instruments; 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.
Active Comparator: Standard instrumentation The patient will undergo surgery using standard instrumentation	Device: Standard instrumentation; Standard instrumentation will be used during total knee replacement surgery.

Outcome Measures

Primary Outcome Measures

1. Implant alignment [6 weeks]

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

Secondary Outcome Measures

1. Oxford Knee Score [1yr, 5yr, 10yr]

   Patient questionnaire

Other Outcome Measures

1. EUROQOL-5D [1 year, 5 years and 10 years]

2. IKKS Score [1yr, 5 yr, 10yr]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rotherham District General Hospitals NHS Trust	Rotherham	South Yorkshire	United Kingdom	S60 2UD
2	Sheffield Teaching Hospital NHS Trust	Sheffield	South Yorkshire	United Kingdom	S5 7AU

Sponsors and Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

• Principal Investigator: Caroline Blakey, MBChB, Sheffield Teaching Hospitals NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02096393
• Other Study ID Numbers: STH16313
• First Posted: Mar 26, 2014
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Osteoarthritis, Knee

Study Results

No Results Posted as of Jun 9, 2022