A clinical study to assess whether there is a difference in outcomes in patients receiving either the PFC or the Attune knee replacement

Early functional outcomes after evolutionary total knee arthroplasty: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10345709

Enrollment

150

Registered

2020-10-06

Start date

2014-12-01

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of knee Musculoskeletal Diseases Osteoarthritis of knee

Interventions

The study is designed as a single-blinded randomized controlled trial with patients blinded to their treatment arm. Subjects will remain blinded as to their treatment arm for the duration of the trial

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 22 to 90 years old inclusive 2. A diagnosis of non-inflammatory osteoarthritis of the knee 3. Primary varus osteoarthritic deformity 4. Stable collateral ligaments at the time of pre-operative clinical examination 5. Patient is a candidate for routine primary knee arthroplasty (cruciate retaining) in line with manufacturer guidelines 6. Subject is able to give consent to the procedure

Exclusion criteria

Exclusion criteria: 1. A patient with a diagnosis of inflammatory osteoarthritis 2. Severe bone defects or deformity which will require augmentation with bone graft or augmented prosthesis or a constrained device 3. Valgus osteoarthritis 4. Previous patellectomy 5. Patient has a contralateral TKR which is a PFCTM or ATTUNETM implant 6. Patient has a poorly functioning or symptomatic contra-or ipsilateral total hip replacement 7. Previous lower limb amputation on either limb 8. Previous fractures, osteotomy or surgery to the knee which required metal implantation and/or ligament reconstruction 9. Neurogenic cause for arthritis in the knee or associated neurological symptoms in lower limb referred from spine

Design outcomes

Secondary

Measure	Time frame
1. Knee function measured using the OKS-APQ Questionnaire at baseline, 6 weeks, 3 months and 1 year 2. Knee function measured using the PKIP Questionnaire at baseline, 6 weeks, 3 months and 1 year 3. General health measured using the SF-36 Questionnaire at baseline and 1 year 4. Quality of life measured using the EQ5D-5L Questionnaire at baseline, 6 weeks, 3 months and 1 year 5. Pain measured using VAS Questionnaire at baseline, 6 weeks, 3 months and 1 year 6. Range of movement measured using a Goniometer at baseline, 6 weeks, 3 months and 1 year	—

Measure

Time frame

1. Knee function measured using the OKS-APQ Questionnaire at baseline, 6 weeks, 3 months and 1 year 2. Knee function measured using the PKIP Questionnaire at baseline, 6 weeks, 3 months and 1 year 3. General health measured using the SF-36 Questionnaire at baseline and 1 year 4. Quality of life measured using the EQ5D-5L Questionnaire at baseline, 6 weeks, 3 months and 1 year 5. Pain measured using VAS Questionnaire at baseline, 6 weeks, 3 months and 1 year 6. Range of movement measured using a Goniometer at baseline, 6 weeks, 3 months and 1 year

—

Primary

Measure	Time frame
Knee function measured using the Oxford Knee Score at baseline, 6 weeks, 3 months and 1 year	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026