NCT02482493

Brief Summary

Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures. Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main goal of TKA is to relieve the disabling pain of arthritic disease. Patient satisfaction following TKA is related to quick recovery and return to daily activities. This can be dependent on the design of the implant used in the knee. Improvements in implant design and surgical technique mean many modern designs offer implant survival rates beyond 10 - 15 years. As cost pressure increases in the NHS the unit cost of implants is now being scrutinised, particularly with regard to cost effectiveness. The Press-Fit Condylar (PFC) Sigma implant can be used with either a conventional metal backed or alternatively an all polyethylene tibial component (part fitted to the shin bone), the latter considerably cheaper to manufacture. Four small prospective randomised trials and one large regional registry study with long follow up support the safe use of all polyethylene tibial components in TKA. The investigators will therefore undertake a prospective randomised controlled trial comparing the results of all polyethylene tibial components with those of conventional metal backed tibial components in patients aged 75 or over, comparing both clinical outcome and radiological survivorship. The type of knee replacement used for each patient (metal-backed or polyethylene) will be chosen at random once a patient has agreed to take part in the study. Data will be collected by means of follow-up appointments and questionnaires and clinical tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow us to see how both types of knee replacement perform over time and if one performs better than the other in terms of patients movement, pain and functional activities.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

8.5 years

First QC Date

June 17, 2015

Last Update Submit

November 29, 2024

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • American Knee Society Score

    5 year outcomes

Study Arms (2)

All-polyethylene Tibial component

ACTIVE COMPARATOR

Sigma PFC All polyethylene Tibial component will be implanted

Device: Sigma PFC

Metal Backed Tibial component

ACTIVE COMPARATOR

Sigma PFC metal-backed tibial component will be implanted

Device: Sigma PFC

Interventions

Sigma PFCDEVICE

patients will receive either an all polyethylene tibial component or a metal- backed component

All-polyethylene Tibial componentMetal Backed Tibial component

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients suitable for simple cemented primary knee arthroplasty
  • Patients presenting with osteoarthritis of the knee
  • Patients with inflammatory arthropathy, requiring total knee arthroplasty
  • Patients must be ambulatory at time of preoperative assessment clinic
  • Patients must be able to understand instructions and be willing to return for follow up
  • Patients aged 75 years or over at the time of surgery

You may not qualify if:

  • Previous knee surgery (except arthroscopic / open meniscectomy)
  • Patients with significant medical co-morbidity
  • Disorders causing abnormal gait or significant pain
  • Patients unable to consent
  • Severe visual impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma & Orthopaedic Dept, Tunbridge Wells Hospital

Pembury, Kent, TN2 4QJ, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Paul Gibb

    Maidstone and Tunbridge Wells NHS trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr Nick Bowman- Consultant Orthopaedic Surgeon

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 26, 2015

Study Start

January 1, 2017

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

GB(1)