A comparison between robotic and orthosensor-assisted total knee replacement and standard total knee replacement surgery

Robotic and Orthosensor Assisted versus Manual (ROAM) total knee replacement: A randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47889316

Enrollment

Registered

2020-01-10

Start date

2019-05-09

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Arthrosis of knee Musculoskeletal Diseases Arthrosis of knee

Interventions

A randomised controlled trial will be conducted to compare the outcomes of patients undergoing a conventional manual knee replacement to those undergoing TKR using robotic assisted surgery and the Ort

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Listed for elective primary TKR for end stage osteoarthritis under the care of the two participating surgeons 2. Male or female, age 45 – 85 at the time of listing for surgery 3. Suitable candidate for a cruciate retaining TKR (Triathlon prosthesis)

Exclusion criteria

Exclusion criteria: 1. Incompetent MCL (grade III in laxity) observed by consultant on examination 2. Unable to comply with the study protocol (incl. refusal for CT scan) 3. Pregnant, lactating or planning pregnancy during the course of the study 4. Requires patella resurfacing 5. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study

Design outcomes

Primary

Measure	Time frame
Early functional outcome (measured by the WOMAC) from baseline to 6 months following TKR	—

Secondary

Measure	Time frame
1. Knee function in activities of daily living measured by the Oxford Knee Score (OKS) from baseline to 8 weeks, 6 and 12 months 2. Joint awareness measured by the Forgotten Joint Score (FJS) from baseline to 8 weeks, 6 and 12 months 3. Satisfaction after total knee replacement measured using a validated outcome measure at 8 weeks, 6 and 12 months 4. Pain, stiffness and functional ability measured using components of the WOMAC at 8 weeks, 6 and 12 months and function at 8 weeks and 12 months 5. Health-related quality of life measured using the EQ-5D-3L at baseline, 8 weeks, 6 and 12 months 6. Cost-effectiveness of the two interventions from a UK NHS perspective measured using a health service resource use questionnaire will be completed by the patient at the 8 weeks, 6 and 12 month post-surgical research assessment. Inpatient and surgical data will be collected on the case report forms (CRF’s) and complications will be recorded at each visit. The tariffs associated with surgery, in-patient stay, follow up visits and any treatment for complications will be retrieved from hospital finance records at the end of the follow up period 7. Gait patterns and balance (centre of pressure excursion) will be measured using a TekScan instrumented walkway over which patients walk and stand. Activity levels will be monitored in a sub-set of patients using ActivPal activity monitors. Gait/balance/activity will be monitored pre-surgery and at 12 months post-surgery.	—

Measure

Time frame

1. Knee function in activities of daily living measured by the Oxford Knee Score (OKS) from baseline to 8 weeks, 6 and 12 months 2. Joint awareness measured by the Forgotten Joint Score (FJS) from baseline to 8 weeks, 6 and 12 months 3. Satisfaction after total knee replacement measured using a validated outcome measure at 8 weeks, 6 and 12 months 4. Pain, stiffness and functional ability measured using components of the WOMAC at 8 weeks, 6 and 12 months and function at 8 weeks and 12 months 5. Health-related quality of life measured using the EQ-5D-3L at baseline, 8 weeks, 6 and 12 months 6. Cost-effectiveness of the two interventions from a UK NHS perspective measured using a health service resource use questionnaire will be completed by the patient at the 8 weeks, 6 and 12 month post-surgical research assessment. Inpatient and surgical data will be collected on the case report forms (CRF’s) and complications will be recorded at each visit. The tariffs associated with surgery, in-patient stay, follow up visits and any treatment for complications will be retrieved from hospital finance records at the end of the follow up period 7. Gait patterns and balance (centre of pressure excursion) will be measured using a TekScan instrumented walkway over which patients walk and stand. Activity levels will be monitored in a sub-set of patients using ActivPal activity monitors. Gait/balance/activity will be monitored pre-surgery and at 12 months post-surgery.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026