Total or Partial Knee Arthroplasty Trial

NCT01352247 | Completed DMC

• 2 other identifiers: 09/H0606/88ISRCTN03013488
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain and Function

  This will be measured by using the Oxford Knee Score, a patient reported outcome questionnaire.

  Year 5 (additional extended follow-up to 10 years)

Secondary Outcomes (4)

• Range of Motion and Function

  Year 5

• Activity level

  Year 5 (additional extended follow-up to 10 years)

• Economic Evaluation

  Year 5 (additional extended follow-up to 10 years)

• Patient Satisfaction

  Year 5 (additional extended follow-up to 10 years)

Study Arms (2)

Unicompartmental Knee Replacement

EXPERIMENTAL

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.

Procedure: Unicompartmental Knee Replacement

Total Knee Replacement

EXPERIMENTAL

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.

Procedure: Total Knee Replacement

Interventions

Unicompartmental Knee Replacement PROCEDURE

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.

Unicompartmental Knee Replacement

Total Knee Replacement PROCEDURE

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.

Total Knee Replacement

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• University of Aberdeen: collaborator

Study Sites (1)

Nuffield Orthopaedic Centre NHS Trust

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Related Publications (5)

• Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK. Total versus partial knee replacement in patients with medial compartment knee osteoarthritis: the TOPKAT RCT. Health Technol Assess. 2020 Apr;24(20):1-98. doi: 10.3310/hta24200.

  PMID: 32369436 BACKGROUND

• Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.

  PMID: 31326135 RESULT

• Beard DJ, Davies LJ, Cook JA, MacLennan G, Hudson J, Price AJ, Carr AJ, Little M, Leal J, Fitzpatrick R, Murray DW, Campbell MK; TOPKAT Study Group. Assessing clinical and cost effectiveness of total versus partial knee replacement (TOPKAT): 10-year follow-up of a multicentre, randomised controlled trial. Lancet Rheumatol. 2025 Nov 18:S2665-9913(25)00250-4. doi: 10.1016/S2665-9913(25)00250-4. Online ahead of print.

  PMID: 41270774 DERIVED

• Patel R, Tilling K, Lawlor DA, Howe LD, Bogdanovich N, Matush L, Nicoli E, Kramer MS, Martin RM. Socioeconomic differences in childhood length/height trajectories in a middle-income country: a cohort study. BMC Public Health. 2014 Sep 8;14:932. doi: 10.1186/1471-2458-14-932.

  PMID: 25200513 DERIVED

• Beard D, Price A, Cook J, Fitzpatrick R, Carr A, Campbell M, Doll H, Campbell H, Arden N, Cooper C, Davies L, Murray D. Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial. Trials. 2013 Sep 12;14:292. doi: 10.1186/1745-6215-14-292.

  PMID: 24028414 DERIVED

Related Links

• Trial Website
• Surgical Intervention Trials Unit (SITU): Coordinating Centre

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• David Beard, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

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 20, 2011
• First Posted: May 11, 2011
• Study Start: January 1, 2010
• Primary Completion: September 1, 2018
• Study Completion: June 20, 2024
• Last Updated: April 4, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)