Comparison of rehabilitation outcomes after total knee arthroplasty with and without tourniquet use

Comparison of rehabilitation outcomes after total knee arthroplasty with and without tourniquet use: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN85166072

Enrollment

Registered

2012-07-12

Start date

2012-09-01

Completion date

Unknown

Last updated

2018-11-19

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

Conditions

Total knee arthroplasty Surgery

Interventions

Only senior orthopaedic surgeons who have previous experience from both operative procedures participate in the trial with a minimum of three operations from each procedure. Each surgeon operates ha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 50 to 80 2. Cause of surgery arthrosis 3. Total knee replacement (NexGen)

Exclusion criteria

Exclusion criteria: 1. Reoperative surgery. 2. Valgus deformity (> 30°) 3. Those having one-stage bilateral procedures 4. Rheumatoid arthritis 5. Secondary arthrosis 6. Body mass index (BMI) > 35 Added 12/11/2014: 7. Medical grounds discovered by the surgeon after randomization

Design outcomes

Primary

Measure	Time frame
Active Range of Motion (AROM) in the knee is measured before surgery, at day 3 and at 3-month control with a goniometer, with the patient lying supine. Added 12/11/2014: Follow-up also at 2 years.	—

Secondary

Measure	Time frame
1. Timed up and go (TUG) is carried out before surgery, at day 3 and at 3-month control. TUG is a functional test in which the time taken for the patient to get up from a chair, walk three meters, turn and sit down again is measured. 2. Visual Analaogue Scale (VAS) is used for pain assessment. The patient answers the question ?How painful is your leg?? according to a 0-10 scale. This is done before surgery, 24 hours after surgery, 72 hours after surgery (+- 2 hrs) and at a 3-month control. The question is asked prior to training, while the patient is at rest and any additional analgesia given is noted. 3. Swelling is assessed by measuring the circumference 10cm proximal to the superior border of the patella, at the superior border of the patella and 10 cm distal to the superior border of the patella with the patient lying supine. This is done prior to surgery, at day 3 and at a 3-month control. 4. Quadriceps function is tested by the patient being asked to perform a straight leg raise while lying supine with the other leg in flexion with the foot on the base of support. The result is noted as able to/ not able to perform the action. This is carried out prior to surgery, at day 3 and at the 3-month control. Added 12/11/2014: at 2 years the outcomes above will be assessed along with the following additional outcomes: 5. Gait speed is assessed using the 10-meter walk test. Patients are asked to walk as quickly and safely as possible for 14 meters, of which the middle 10 meters are timed. 6. The patients are asked to fill in the Oxford-12 Item Knee Score which is a well-validated outcome questionnaire, designed for use with knee arthroplasty patients.	—

Measure

Time frame

1. Timed up and go (TUG) is carried out before surgery, at day 3 and at 3-month control. TUG is a functional test in which the time taken for the patient to get up from a chair, walk three meters, turn and sit down again is measured. 2. Visual Analaogue Scale (VAS) is used for pain assessment. The patient answers the question ?How painful is your leg?? according to a 0-10 scale. This is done before surgery, 24 hours after surgery, 72 hours after surgery (+- 2 hrs) and at a 3-month control. The question is asked prior to training, while the patient is at rest and any additional analgesia given is noted. 3. Swelling is assessed by measuring the circumference 10cm proximal to the superior border of the patella, at the superior border of the patella and 10 cm distal to the superior border of the patella with the patient lying supine. This is done prior to surgery, at day 3 and at a 3-month control. 4. Quadriceps function is tested by the patient being asked to perform a straight leg raise while lying supine with the other leg in flexion with the foot on the base of support. The result is noted as able to/ not able to perform the action. This is carried out prior to surgery, at day 3 and at the 3-month control. Added 12/11/2014: at 2 years the outcomes above will be assessed along with the following additional outcomes: 5. Gait speed is assessed using the 10-meter walk test. Patients are asked to walk as quickly and safely as possible for 14 meters, of which the middle 10 meters are timed. 6. The patients are asked to fill in the Oxford-12 Item Knee Score which is a well-validated outcome questionnaire, designed for use with knee arthroplasty patients.

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Countries

Sweden

Outcome results

None listed

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