Influence of Different Prostheses on Postoperative Clinical Function in Total Knee Arthroplasty

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

Exploring differences in knee function after surgery with different types of prostheses(Cruciate ligament retaining(CR) VS. posterior stabilizing(PS))

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 45-80 years, any gender, BMI < 35 kg/m2

Initial diagnosis of bilateral knee OA (Kellgren-Lawrence classification grades 3 or 4). Patients who are to undergo simultaneous primary bilateral knee arthroplasty

Inversion deformity ≤ 15°

Posterior cruciate ligament integrity

Disqualifiers

History of knee surgery (ligament, osteotomy, etc.)

knee flexion<90°.

flexion contracture of one knee > 10°

Comorbidity with other diseases, such as peripheral neuropathy, malignant tumors, rheumatism, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CR prosthesis

    Device

    For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.

  • PS prosthesis

    Device

    For patients undergoing simultaneous bilateral knee arthroplasty, different prostheses (CR vs. PS) were randomized to the left or right knee.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Knee Society Score, KSS

Use of Knee Society Score scales for assessment. Including pain, mobility, stability, the patient\&#39;s ability to walk, up and down the stairs, etc. on the assessment, 85-100 is excellent, 70-84 is good, 60-69 is pass, less than 60 is poor

Time frame
6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Secondary outcomes

1

WOMAC

The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a composite outcome measure consisting of multiple measures: pain, stiffness and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Time frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
2

Stride length

The step length data were collected using a gait analysis instrument to analyze whether there was a difference between the right and left sides.

Time frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
3

Stride frequency

The step frequency data were collected using an instrument to analyze whether there were any differences.

Time frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery
4

Percentage of stance phase

The stance phase is the time during which the lower limbs are in contact with the ground and are subjected to gravity, and accounts for 60% of the walking cycle. In walking disorders, the prolongation of the stance phase is often associated with impaired walking.

Time frame
Preoperative, 6 weeks, 3 months, 6 months, 12 months, 24 months after surgery

Other outcomes

Sponsors and contacts

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