Comparing functional recovery after custom or standard total knee replacement

The Origin Study: A randomised control trial comparing functional recovery after custom or standard total knee replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91044823

Enrollment

Registered

2021-02-22

Start date

2020-09-01

Completion date

Unknown

Last updated

2026-01-27

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

Conditions

Total knee replacement for knee osteoarthritis Musculoskeletal Diseases Knee osteoarthritis, arthrosis

Interventions

This study will use a double-blinded (participants and assessors at EHU), randomised control trial using a qualitative, experimental design to investigate: 1. How does functional recovery (joint movem

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Able to walk 10 m unaided, rise from a seated position, or walk up 3 steps unaided 3. Willing and able to give informed consent TKR groups: 1. Due to undergo unilateral TKR due to osteoarthritis Healthy group: 2. No known conditions which would influence movement patterns

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI) >40 2. Knee varus or valgus deformities >15° 3. Severe flexion contracture >15° 4. Known neurological diseases/conditions or impaired balance 5. Dementia or condition which would impair capacity 6. Communication problems that would result in the inability to follow instructions in English 7. Simultaneous bilateral procedure required 8. Active local or systemic infection 9. Immunocompromised 10. Fibromyalgia 11. Loss of bone or musculature, osteonecrosis, or neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified 12. Prior arthroplasty of the affected knee, including high tibial osteotomy 13. Allergy to implant material 14. Growth restricted patients

Design outcomes

Primary

Measure	Time frame
1. Perceptions of pain and joint function measured using the following at baseline, 3 and 12 months for those receiving total knee replacement (TKR): 1.1. Oxford Knee Score numerical rating scale 1.2. Forgotten Joint Score-12 questionnaire 1.3. EuroQol 5-dimension (EQ5D) quality of life questionnaire 1.4. Activities and Specific Balance Confidence Scale (ABC) numerical rating scale 1.5. Question asking which TKR they believe they have received 2. Dynamic function measured using the following at baseline, 3 and 12 months for those receiving total knee replacement (TKR), and baseline and 6 weeks for healthy controls 2.1. Hip, knee, and ankle joint motion and loading during walking, sit-to-stand, and stair ascent and descent movement tasks recorded by a 3D motion capture system 2.2. Ground reaction force data recorded using two force plates 2.3. Segmental accelerations throughout the movement tasks recorded by tri-axial accelerometers (Upper Back, Pelvis, and Bilateral Upper and Lower Legs) 2.4. Activity of the quadriceps and hamstring muscles quantified using electromyography (EMG) 3. Range of motion measured using 3D motion capture and 2D video capture of maximal knee flexion and extension whilst lying supine at baseline, 3 and 12 months for those receiving total knee replacement (TKR), and baseline and 6 months for healthy controls	—

Measure

Time frame

1. Perceptions of pain and joint function measured using the following at baseline, 3 and 12 months for those receiving total knee replacement (TKR): 1.1. Oxford Knee Score numerical rating scale 1.2. Forgotten Joint Score-12 questionnaire 1.3. EuroQol 5-dimension (EQ5D) quality of life questionnaire 1.4. Activities and Specific Balance Confidence Scale (ABC) numerical rating scale 1.5. Question asking which TKR they believe they have received 2. Dynamic function measured using the following at baseline, 3 and 12 months for those receiving total knee replacement (TKR), and baseline and 6 weeks for healthy controls 2.1. Hip, knee, and ankle joint motion and loading during walking, sit-to-stand, and stair ascent and descent movement tasks recorded by a 3D motion capture system 2.2. Ground reaction force data recorded using two force plates 2.3. Segmental accelerations throughout the movement tasks recorded by tri-axial accelerometers (Upper Back, Pelvis, and Bilateral Upper and Lower Legs) 2.4. Activity of the quadriceps and hamstring muscles quantified using electromyography (EMG) 3. Range of motion measured using 3D motion capture and 2D video capture of maximal knee flexion and extension whilst lying supine at baseline, 3 and 12 months for those receiving total knee replacement (TKR), and baseline and 6 months for healthy controls

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed

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