I-ONE® therapy to improve pain and clinical outcomes after partial knee replacement

I-ONE® therapy as an effective completion of medial unicompartmental knee arthroplasty: a prospective randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67242974

Enrollment

Registered

2021-02-08

Start date

2014-11-03

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Isolated medial unicompartmental knee osteoarthritis Musculoskeletal Diseases Isolated medial unicompartmental knee osteoarthritis

Interventions

At recruitment, participants will be subject to baseline assessment using history and objective examination, Visual Analogue Scale (VAS) for knee pain, Knee swelling assessment, Oxford Knee Score, SF-

from day two, started an active progressive mobilization of the joint and assisted walking with two crutches. Gradually and according to each patient, it was therefore recommended to increase the load

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 60 and 85 years 2. Chronic and debilitating knee pain 3. Medial compartment osteoarthritis, with varus or valgus deformity not exceeding 3° respectively, a range of motion >100° with less than 10° of flexion contracture, integrity of anterior and posterior cruciate ligaments, and intact lateral meniscus

Exclusion criteria

Exclusion criteria: 1. Previous knee infection 2. Total hip arthroplasties 3. Rheumatoid arthritis, autoimmune and systemic diseases or tumors 4. Severe malalignment 5. Body mass index (BMI) >30 kg/m² 6. Missing data 7. Revision surgery 8. Received previous surgery of the affected knee (except arthroscopy for meniscectomy)

Design outcomes

Primary

Measure	Time frame
1. Pain measured using a Visual Analogue Scale (VAS) at baseline, 1, 2, 6, 12, and 36 months. The scale uses a 10 cm horizontal line corresponding to a scale evaluating the pain, where the left end stands for the complete absence of pain and the right end the maximum possible pain or unbearable pain.	—

Secondary

Measure	Time frame
1. Swelling, joint function, and ambulation measured using the Oxford Knee Score (OKS), short Form 36 (SF-36) health survey questionnaire, and circumference of the knee at midpatellar height in the supine position, at baseline, 1, 2, 6, 12, and 36 months 2. Complication of normal daily activities due to knee pain measured using the Modified Cincinnati Rating System Questionnaire at baseline, 1, 2, 6, 12, and 36 months 3. Consumption of Non-Steroidal Anti-inflammatory Drug (NSAID) measured through interviews at baseline, 1, 2, 6, 12, and 36 months	—

Measure

Time frame

1. Swelling, joint function, and ambulation measured using the Oxford Knee Score (OKS), short Form 36 (SF-36) health survey questionnaire, and circumference of the knee at midpatellar height in the supine position, at baseline, 1, 2, 6, 12, and 36 months 2. Complication of normal daily activities due to knee pain measured using the Modified Cincinnati Rating System Questionnaire at baseline, 1, 2, 6, 12, and 36 months 3. Consumption of Non-Steroidal Anti-inflammatory Drug (NSAID) measured through interviews at baseline, 1, 2, 6, 12, and 36 months

—

Countries

Italy

Outcome results

None listed

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