Gait in Fixed Or Rotating Cementless Total Knee Arthroplasties
NCT Number: NCT06483178
Acronym: G-FORCE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Arthroplasty|Knee Osteoarthritis
Interventions: DEVICE: Attune knee implant|DEVICE: Triathlon knee implant
Sponsor: Belfast Health and Social Care Trust
Collaborators: Imperial College London|Trauma and Orthopaedics Research Charity
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2027-12
Locations: Musgrave Park Hospital, Belfast, United Kingdom

Summary:
The number of patients requiring knee replacements is increasing every year due to the combination of an aging population, increased patient expectancy, and rising levels of obesity. Therefore, newer implants, or design features, are introduced on a regular basis to try to improve patient outcomes. In 2013, DePuy Synthes launched the Attune Knee System to provide improved range of motion and address the unstable feeling some patients experience whilst performing everyday activities, such as going down stairs. The Attune cementless rotating platform knee was first implanted in September 2016. In 2004, the first Triathlon total knee designed by Stryker was implanted. Registry figures for both the Attune and Triathlon knees are promising with good implant longevity and outcomes.

There is only a small amount of literature available on the Attune knee as it is still a relatively new implant. Worldwide, the Triathlon is widely used and is also a well-established, successful implant used in the investigators' unit. This study will help to determine whether the Attune can improve patient outcomes in terms of gait analysis assessed by walking on a treadmill, patient reported outcome measures and X-ray outcomes when compared to the Triathlon knee. 90 patients who will undergo knee replacement and meet the inclusion criteria and agree to take part will be randomly placed in one of two groups to receive either the Attune or Triathlon knee implant.

Primary Outcome Measures: Post-operative top downhill walking speed at 9-12 months., Post-operative top downhill walking speed at 9-12 months will be assessed via gait analysis., 9-12 months
Secondary Outcome Measures: Ground reaction forces in the vertical plane throughout the stance phase of the gait cycle., 9-12 months|Ground reaction forces in the medio lateral plane throughout the stance phase of the gait cycle., 9-12 months|Ground reaction forces in the anterior posterior plane throughout the stance phase of the gait cycle., 9-12 months|Gait symmetry at weight acceptance (heel strike) of the stance phase, 9-12 months|Gait symmetry at mid-stance of the stance phase, 9-12 months|Gait symmetry at push off of the stance phase, 9-12 months|Spatiotemporal gait parameter - step length, 9-12 months|Spatiotemporal gait parameter - stride length, 9-12 months|Spatiotemporal gait parameter - step width, 9-12 months|Spatiotemporal gait parameter - step time, 9-12 months|Spatiotemporal gait parameter - double support time, 9-12 months|Pain Visual Analogue Score (VAS), The Pain VAS score will be completed by participants online with a score ranging from zero to 100 with 0 being no pain and 100 being worst pain imaginable., Pre-operation, post-operatively weekly from Week 1 to Week 6, 3 months and 12 months.|Oxford Knee Score (OKS), The OKS will be completed by participants online, with a score ranging from 0 (worst score possible) - 48 (best score possible)., Pre-operation, 3 months and 12 months.|EuroQoL-5D (EQ-5D-5L), The EQ-5D-5L will be completed by participants online. A single score will be derived which ranges from -0.594 to 1, where 0 is death and 1 is full health., Pre-operation, 3 months and 12 months.|EuroQoL-5D Visual Analogue Scale (VAS), The EQ-5D VAS will also be scored from 0 (worst health possible) - 100 (best health possible)., Pre-operation, 3 months and 12 months.|Forgotten Joint Score (FJS), The FJS will also be completed by participants online, with every question scored 1 (never) to 5 (mostly). The raw score ranges from 12 to 60 and this score is then used to give a final score with the higher the score the better outcome.

Final score = 100 - ((sum (Item 1 to Item 12) - 12)/48\*100), Pre-operation, 3 months and 12 months.|Feller's Patellar score, The questionnaire includes items on anterior knee pain, quadriceps strength, ability to rise from a chair and climb stairs; these scores range from 3 to 30 points, with 30 points representing the best possible score., Pre-operation, 3 months and 12 months.|Range of motion (ROM), ROM will be assessed face-to-face pre-operatively, virtually at 6 weeks, and face-to-face at 3 months and 12 months if convenient for the patient. If ROM cannot be taken face-to-face at 3 months or 12 months, ROM will be assessed virtually. To do this, participants will email photos of their knee following guidance from a participant information sheet. These photos will then be uploaded to the DrGoniometer app to take the measurements of ROM. Three readings of ROM will be recorded:

1. Extension
2. Active flexion
3. Forced passive flexion performed by the participant, Pre-operation, 6 weeks, 3 months and 12 months.|Length of stay in hospital, Total length of stay in hospital will be calculated using date of discharge and date of operation., Up to 4 months|90-day complications, This will include Out of Hour attendances, A\&E attendances, readmissions to hospital and any returns to theatre., 3 months