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A study on the application of a soft tissue tension measurement device in total knee arthroplasty

A study on the application of a soft tissue tension measurement device in total knee arthroplasty

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124286
Enrollment
Unknown
Registered
2026-05-09
Start date
2025-08-13
Completion date
Unknown
Last updated
2026-05-11

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

Conditions

Knee Osteoarthritis (End-stage)

Interventions

Intervention group:The surgeon can obtain pressure data in real time and adjust soft tissue balance accordingly.
Control group:The surgeon was unable to obtain pressure data and relied solely on traditional experience to complete the surgery

Sponsors

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with primary osteoarthritis scheduled to undergo primary total knee arthroplasty (aged >50 and =80 years); 2. No major contraindications to surgery as determined by clinical and laboratory examinations; 3. Patients who agree to undergo soft tissue balance assessment using a soft tissue tension measurement device; 4. Patients with good compliance who are willing and able to undergo follow-up as required and to sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Patients with active knee infection or systemic infection; 2. Patients undergoing primary total knee arthroplasty for conditions other than primary osteoarthritis, such as rheumatoid arthritis, tuberculous arthritis, post-traumatic arthritis, etc.; 3. Patients deemed unable to tolerate surgery due to cardiopulmonary insufficiency based on clinical and laboratory evaluations; 4. Patients with mental disorders who are unable to cooperate with treatment; 5. Women who are breastfeeding or pregnant; 6. Patients with poor compliance who are unable to complete follow-up assessments at key time points; 7. Patients deemed by the investigators to be unable to complete the study for any reason.

Design outcomes

Primary

MeasureTime frame
Knee Society Score;

Secondary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index;EuroQol 5-Dimension;Visual Analogue Scale;Gait analysis;thigh circumference;calf circumference;joint circumference;skin temperature;flexion range of motion;extension range of motion;white blood cells;hemoglobin;C-reactive protein;erythrocyte sedimentation rate;hip-knee-ankle angle;lateral distal femoral angle;medial proximal tibial angle;Tourniquet application time;duration of surgery;intraoperative adjustments;baroreceptor pad measurement time;Intraoperative baroreceptor measurements;

Countries

China

Contacts

Public ContactLi Huiwu

Shanghai Ninth People’s Hospital, Shanghai Jiao Tong University School of Medicine

huiwu1223@163.com+86 131 2264 9860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026