The Assessment of Patient Specific Instrumentation for Unicompartmental Knee Replacement

NCT02748096 | Completed Results DMC

• 1 other identifier: 7110
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patient-specific instrumentation guides have previously been used to improving surgical accuracy and ease of implantation during Total Knee Replacement but have received less attention for implanting Unicompartmental Knee Replacement. The aim of this prospective study is to compare the accuracy of implantation and functional outcome of mobile bearing medial Unicompartmental Knee Replacement implanted with and without patient specific instrumentation by experienced knee surgeons.

Conditions

Knee Arthritis

Keywords

Unicompartmental Knee Replacement; Patient Specific Instrumentation

Outcome Measures

Primary Outcomes (1)

• Radiological Assessment of Component Positioning

  Radiological assessment of component positioning and alignment based on post-operative knee radiographs.

  Within a weeks after surgery

Secondary Outcomes (1)

• Assessment of Functional Outcome

  One year after surgery

Other Outcomes (2)

• Post-operative Change in Haemoglobin Between Baseline Baseline and 48 Hours After Surgery

  Within the first 48 hours after surgery

• Number of Participants With The Need for Blood Transfusion Following Surgery

  Within the first 48 hours after surgery

Study Arms (2)

Patient Specific Instrumentation

EXPERIMENTAL

Patients undergoing unicompartmental knee replacement with the additional aid of patient specific instrumentation.

Procedure: Patient Specific Instrumentation

Conventional Instrumentation

ACTIVE COMPARATOR

Patients undergoing unicompartmental knee replacement using standard instrumentation.

Procedure: Conventional Instrumentation

Interventions

Patient Specific Instrumentation PROCEDURE

Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).

Patient Specific Instrumentation

Conventional Instrumentation PROCEDURE

Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.

Conventional Instrumentation

Eligibility Criteria

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

You may qualify if:

• Both cruciate ligaments functionally intact
• Full thickness cartilage in the lateral compartment
• Correctable intra-articular varus deformity
• Full thickness cartilage loss in the medial compartment

You may not qualify if:

• Contra-indication for MRI
• All forms of inflammatory arthritis

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Results Point of Contact

• Title: Professor Anrew Price
• Organization: University of Oxford

andrew.price@ndorms.ox.ac.uk

+44 1865 223421

Study Officials

• Andrew Price, FRCS PhD

  Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 22, 2016
• Study Start: March 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2014
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share