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Total or Partial Knee Arthroplasty Trial (TOPKAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01352247
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
University of Aberdeen
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE April 20, 2011
First Posted Date  ICMJE May 11, 2011
Last Update Posted Date August 9, 2019
Study Start Date  ICMJE January 2010
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
Pain and Function [ Time Frame: Year 5 (additional extended follow-up to 10 years) ]
This will be measured by using the Oxford Knee Score, a patient reported outcome questionnaire.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
Pain and Function [ Time Frame: Year 5. ]
This will be measured by using the Oxford Knee Score, a pateint reported outcome questionnaire.
Change History Complete list of historical versions of study NCT01352247 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Range of Motion and Function [ Time Frame: Year 5 ]
    This will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function.
  • Activity level [ Time Frame: Year 5 (additional extended follow-up to 10 years) ]
    This will be measured using two patient reported questionnaires, the University of California, Los Angeles (UCLA) Activity Score and the High Activity Arthroplasty Score.
  • Economic Evaluation [ Time Frame: Year 5 (additional extended follow-up to 10 years) ]
    The EuroQol (EQ-5D) a patient reported questionnaire will provide data for economic evaluation.
  • Patient Satisfaction [ Time Frame: Year 5 (additional extended follow-up to 10 years) ]
    Patient satisfaction will be measured using the Lund Score.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
  • Range of Motion and Function [ Time Frame: Year 5 ]
    This will be measured using the American Knee Society Score (AKSS). A clinician assessed score examining pain, stability, range of movement and function.
  • Activity level [ Time Frame: Year 5. ]
    This will be measured using two patient reported questionnaires, the University of California, Los Angeles (UCLA) Activity Score and the High Activity Arthroplasty Score.
  • Economic Evaluation [ Time Frame: Year 5. ]
    The EuroQol (EQ-5D) a patient reported questionnaire will provide data for economic evaluation.
  • Patient Satisfaction [ Time Frame: Year 5. ]
    Patient satisfaction will be measured using the Lund Score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Total or Partial Knee Arthroplasty Trial
Official Title  ICMJE Total or Partial Knee Arthroplasty Trial
Brief Summary

In the majority of patients with osteoarthritis of the knee the disease originates in the medial compartment. There are two different approaches to replacing this arthritic area. Some surgeons feel that it is always best to replace both the knee compartments with a Total Knee Replacement (TKR). Others feel it is best to replace just the damaged component of the knee with a Unicompartmental Knee Replacement (UKR). There is little agreement amongst knee surgeons. Both interventions are established and well documented procedures, yet little evidence exists to support either practice. Each intervention is considered standard care. There exists little evidence, however, to prove the clinical and cost effectiveness of either management option.

The aim of the Total or Partial Knee Arthroplasty Trial (TOPKAT) will be to assess the clinical and cost effectiveness of Total Knee Replacements versus Unicompartmental Knee Replacements in patients with medial osteoarthritis. This will be examined using an appropriate patient base and long term assessments.

The trial has a combined device/expertise based allocation depending on the local situation. Surgeons who are in equipoise and have sufficient experience to perform both TKR and UKR, randomisation and allocation can be based on "device" (UKR or TKR). The same surgeon will perform the operation for both arms of the study.

For surgeons who hold a preference for one treatment over the other, an "expertise" based randomisation will then occur. UKR surgeons will work alongside TKR surgeons. Patients recruited to the study from these sites will be randomised to one of the treatment options and treated by the appropriate surgeon. In such cases the patient is internally referred to the other surgeon's operating list.

Patients will be recruited by their consultant knee surgeons in collaboration with the local research team. TOPKAT are hoping to recruit 500 patients altogether, with 250 per arm of the trial.

Detailed Description

The design of the study is a single layer multicentre superiority type randomised controlled trial of unilateral knee replacement patients. The randomised controlled trial design will help reduce and prevent potential bias influencing the evaluation.

Participants will be randomised to either UKR or TKR. The trial has a combined equipoise/expertise approach. It enables surgeons who are not in equipoise to deliver only one of the two operations while also allowing surgeons in equipoise to provide both operations. A surgeon who is in equipoise ('equipoise surgeon') and has sufficient experience to perform both TKR and UKR will deliver the allocated operation (UKR or TKR). The same surgeon will perform the operation for both arms of the study.

Not all surgeons are able to exhibit this equipoise. They may hold a preference for one treatment over the other often due to experience/expertise with one type of operation. Interestingly, a surgeon may also believe the patient may benefit from one particular operation even though they may not be able to perform it themselves.

Equipoise is difficult to investigate or establish. Self declaration has been used as the main approach but in order to sufficiently secure this state the following aspects are important:

  • The equipoise considered must be patient- or individual-based equipoise rather than an overall or general category equipoise based on operation type. The surgeon must consider their position for each individual patient. Only if they believe that either operation will be suitable for an individual patient can the patient then be recruited.
  • No surgeon will ever knowingly perform what they consider a substandard surgical procedure.

In order to complete the trial by seeking to maximise surgeon participation, an 'expertise'-based delivery of the intervention will also occur. For this approach there must be a surgeon with expertise in TKR and a surgeon with expertise in UKR in the same centre who will act together as a 'delivery unit'. Patients recruited to the study who are under the care of such a surgeon ('expertise surgeon') will be randomised to one of the two groups and treated by the appropriate surgeon. This 'expertise' approach allows for those UKR surgeons who work alongside TKR surgeons to team up and participate in the study. Subsequent surgery may be carried out by a surgeon different to that at the initial consultation. In such cases the patient is internally referred to the other surgeon's operating list. No restriction is made upon the number of delivery units within a centre. A surgeon can only be in one delivery unit, that is, they are either an 'equipoise surgeon' or an 'expertise surgeon'.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Unicompartmental Knee Replacement
    A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure.
  • Procedure: Total Knee Replacement
    A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position.
Study Arms  ICMJE
  • Experimental: Unicompartmental Knee Replacement

    TOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded.

    A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure.

    Intervention: Procedure: Unicompartmental Knee Replacement
  • Experimental: Total Knee Replacement

    TOPKAT will be pragmatic in terms of implant selection for the knee replacement operation. Providing the inclusion criteria are met, surgeons will be entirely free to use an implant of their choice or will use the current implants used at their institution. Implant type used on each patient will be recorded.

    A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position.

    Intervention: Procedure: Total Knee Replacement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2011)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Medial compartment osteoarthritis with exposed bone on both femur and tibia
  • Functionally intact Anterior Cruciate Ligament (superficial damage or splitting is acceptable)
  • Full thickness and good quality lateral cartilage present
  • Correctable intra-articular varus deformity (suggestive of functionally intact medical cruciate ligament)
  • Medically fit showing an American Society of Anesthesiologists (ASA) of 1 or 2

Exclusion Criteria

  • Require revision knee replacement surgery
  • Have rheumatoid arthritis or other inflammatory disorders
  • Are unlikely to be able to perform required clinical assessment tasks
  • Have symptomatic foot, hip or spinal pathology
  • Previous knee surgery other than diagnostic arthroscopy and medial menisectomy
  • Previously had septic arthritis
  • Have significant damage to the patella-Femoral Joint especially on the lateral facet.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01352247
Other Study ID Numbers  ICMJE 09/H0606/88
ISRCTN03013488 ( Registry Identifier: ISRCTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE University of Aberdeen
Investigators  ICMJE
Principal Investigator: David Beard, DPhil University of Oxford
PRS Account University of Oxford
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP