A Study Using Metaphyseal Cones Versus a Cemented Stem Construct in Revision TKR

NCT03169634 | Active Not Recruiting DMC

• 1 other identifier: 1711525
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Lay Person's Summary: Knee replacement surgery has been successfully carried out for many years. However, in time, some knee replacements will fail-usually either because of wear or loosening of the replacement parts. This may mean the patient has to undergo further surgery-this is known as revision total knee replacement (rTKR). This revision surgery is often more complex than the original operation and presents the operating surgeon with several technical challenges. Of particular concern, is that when the old knee replacement is removed, a large cavity can be left in the bone. The new knee replacement has to be placed into this, but it is essential that it is immediately stable and secure. The large cavity has to be somehow either filled in or bypassed to ensure the new knee replacement is secure enough for early weight-bearing and long term survival. Different techniques have been used for many years to overcome this problem. Firstly, it may be possible to simply cement another knee replacement into the cavity- probably needing more cement than was previously used. An alternative option to this is use a device called a "cone" which sits into the bony cavity created by removing the original knee replacement, and a new knee replacement can be cemented into this. Bone grows onto the cone to ensure its stability. The new knee replacement can have either short stemmed components like the original Total Knee Replacement (TKR), or long stemmed components. All of these types of rTKR are presently in use throughout the United Kingdom (UK). At this point in time, no-one knows which type is best. The research team are planning to run this study to see if it is possible to identify which type of rTKR gives the best outcome for patients. The research team will examine the results in different ways including questionnaires to measure how well the patients feel their knee is performing, specific tests to measure knee function, and by using x-rays and scans. The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the research team will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation. The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the investigators will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation. A preliminary analysis of the data generated by the study will be carried out 2.5 years after recruitment of the 1st participant to assess compliance with the study protocol.

Conditions

Total Knee Arthroplasty

Keywords

Failed knee replacement; loosening; wear; reoperation

Outcome Measures

Primary Outcomes (1)

• An assessment of compliance with the study protocol

  For this, the research team will measure compliance of study participants with the pre and post-operative attendance schedule

  2.5 years after recruitment of 1st subject

Secondary Outcomes (32)

• An assessment of numbers recruited to the study by comparing the potential number of recruits to those actually recruited

  2 years after recruitment of 1st subject

• Failure for any reason requiring further revision surgery: including but not exclusive to loosening of the components, infection, instability or pain.

  From day 1 post-op to 5 years post -op

• The assessment of early stability of the newly implanted prosthesis as measured radiographically on x-rays by subsidence

  3 months post-op

• The assessment of early stability of the newly implanted prosthesis as measured radiographically on x-rays by subsidence

  6 months post-op

• The assessment of early stability of the newly implanted prosthesis as measured radiographically on x-rays by subsidence

  12 months post-op

Study Arms (3)

short or long stemmed rTKR cemented

EXPERIMENTAL

Procedure: short or long stemmed rTKR cemented

Cone with short stem

EXPERIMENTAL

Procedure: Cone with short stem

Cone with long stem

EXPERIMENTAL

Procedure: Cone with long stem

Interventions

short or long stemmed rTKR cemented PROCEDURE

An evaluation of the outcomes of different ways of performing revision total knee replacement surgery

short or long stemmed rTKR cemented

Cone with short stem PROCEDURE

Revision knee replacement using a metaphyseal cone and then a knee replacement with short stems is cemented in to it

Cone with short stem

Cone with long stem PROCEDURE

Revision knee replacement using a metaphyseal cone and then a knee replacement with long stems is cemented in to it

Cone with long stem

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing first time revision knee replacement for aseptic loosening or wear of the components
• Patient has signed an ethics committee approved consent form
• rTKR to be performed at The Royal Devon and Exeter Hospital
• AORI class 2 defects of femur and/or tibia
• Skeletally mature male or female
• Patient is willing and able to comply with postoperative scheduled clinical and radiological evaluations and rehabilitation
• Patient must be suitable for a rTKR with the Triathlon TS system i.e. must not have gross collateral ligament laxity

You may not qualify if:

• Refusal to consent to participate in the study
• Patients known to have an infected joint replacement prior to revision surgery
• Patients identified with an unexpected infected joint replacement identified per-operatively
• AORI class 1 defects of tibia or femur where metaphyseal cone fixation is not indicated
• AORI class 3 defects of tibia and femur where distal femoral replacement or proximal tibial replacement is required.
• Cases of ligamentous instability where condylar knee revision is not indicated
• Patient is diagnosed with a systemic disease or metabolic disorder leading to progressive bone deterioration
• Patient has a neuromuscular or neurosensory deficiency
• Patients undergoing patella revision in isolation
• Pregnancy

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter Hospital

Exeter, Devon, EX25DW, United Kingdom

Location

Study Officials

• Andrew Toms, MSc FRCS

  RD+E Hospital NHSFT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to study arm allocation. The physiotherapists performing the functional assessments will be blinded to study arm allocation. T
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 3 armed study in which participants are randomised to receive 1 of 3 types of revision total knee arthroplasty

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 30, 2017
• Study Start: June 21, 2017
• Primary Completion (Estimated): June 21, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)