Assessing the safety of removing the inflamed joint lining tissue during knee replacement surgery

A single-centre randomised controlled surgical trial to compare the safety of synovectomy versus no synovectomy during total knee arthroplasty for osteoarthritis in patients with macroscopically inflamed synovium

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31010214

Enrollment

Registered

2016-10-06

Start date

2013-11-01

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases

Interventions

The trial consists of two arms and randomisation is performed intra-operatively by a research nurse attending the operating room using the ‘sealed envelope.com’ website to provide the allocation. Afte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Female and male 3. End stage osteoarthrtitis of the knee requiring arthroplasty

Exclusion criteria

Exclusion criteria: 1. Refusal or inability to provide informed consent 2. Bilateral synchronous procedures 3. Osteoarthritis secondary to auto-immune arthropathy 4. Inability to answer questionnaires due to cognitive impairment 5. Neuromuscular disorders that would perturb rehabilitation 6. BMI more than 40

Design outcomes

Primary

Measure	Time frame
Mean haemoglobin decrease from pre-operatively to day one post-operatively	—

Secondary

Measure	Time frame
1. Range of movement, measured by a research physiotherapist using a goniometer 2. Osteoarthritis symptoms, measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3. Quality of life, measured using the Short Form Health Survey (SF-36) 4. Health status, measured using the EuroQol five dimensions questionnaire (EQ-5D) 5. Patient satisfaction from surgery score All measured pre-operatively, 6 weeks post-operatively and 1 year post-operatively.	—

Measure

Time frame

1. Range of movement, measured by a research physiotherapist using a goniometer 2. Osteoarthritis symptoms, measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3. Quality of life, measured using the Short Form Health Survey (SF-36) 4. Health status, measured using the EuroQol five dimensions questionnaire (EQ-5D) 5. Patient satisfaction from surgery score All measured pre-operatively, 6 weeks post-operatively and 1 year post-operatively.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026