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Osteoarthritis (OA) of the KneeNCT07742696

Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty

A study testing subvastus and medial parapatellar in people with Osteoarthritis (OA) of the Knee, run by Peking University Third Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to compare the effects of the medial parapatellar approach (MP) and the subvastus approach (SV) on postoperative clinical function in total knee arthroplasty (TKA). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Osteoarthritis (OA) of the Knee
What is being tested?
subvastus and medial parapatellar
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteChina
Study dates
15 Jul 2026to 15 Jul 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 50 to 80 who are diagnosed with end-stage knee osteoarthritis that require unilateral primary total knee arthroplasty;
  • Patients who are determined by clinical and laboratory tests to have no absolute surgical contraindications;
  • Patients with good compliance, willing and able to undergo follow-up observations as required and sign the informed consent form;

Who cannot join

  • Patients with a history of surgery on the affected knee joint in the past;
  • Patients with neuromuscular diseases;
  • Patients scheduled for knee joint replacement revision surgery;
  • Patients with active knee joint infection or systemic infection;
  • Patients who receive primary joint replacement due to non-knee osteoarthritis, such as rheumatoid arthritis, tuberculous arthritis, traumatic arthritis, etc;
  • Patients with valgus or varus deformity of the knee joint greater than 15°;
Show all 13Show fewer
  • Patients with knee flexion deformity greater than 15°;
  • Patients whose heart and lung functions are determined by clinical and laboratory tests to be unable to tolerate surgery;
  • Patients with mental disorders who are unable to cooperate with treatment;
  • Patients who is lactating or pregnant;
  • Patients who are unwilling to participate in this study and did not sign the informed consent form;
  • Patients with poor compliance and inability to cooperate in completing the follow-up observers at critical times;
  • For any reason, the researchers believe that the subject is unlikely to complete this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ran Zhao, MD contact

+8613161866294

2411210441@pku.edu.cn

China1 site

  • Orthopaedic Department of Peking University Third Hospital

    Beijing, Haidian

    Orthopaedic Department of Peking University Third Hospital, +8613161866294, 2411210441@pku.edu.cn

Other trials in China

About this study

Official title: Comparison of Postoperative Functional Outcomes Between Subvastus and Medial Parapatellar Approach in Total Knee Arthroplasty: a Prospective Random Controlled Trial

This study aims to compare the effects of the medial parapatellar approach (MP) and the subvastus approach (SV) on postoperative clinical function in total knee arthroplasty (TKA). A total of 84 patients, who visit the Joint Surgery Department of Peking University Third Hospital and are diagnosed with end-stage knee osteoarthritis and require unilateral, primary total knee arthroplasty, will be recruited. The patients will be randomly assigned to two groups, with 42 patients in each group. TKA will be performed using the MP and SV approaches respectively. Postoperative data such as quadriceps muscle strength, the time of first unassisted straight leg raise (SLR), joint range of motion (ROM), KSS score, WOMAC score, SF-12 score, VAS score, and shear wave elastography (SWE) of the medial thigh muscle will be collected. The patients will be followed up for 2 years postoperatively to compare the short-term and long-term clinical functional outcomes of the two surgical approaches.

Being tested
subvastus, medial parapatellar
Keywords
medial parapatellar approach, subvastus approach, total knee arthroplasty
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • subvastusProcedure or surgery

    Patients receive total knee arthroplasty with subvastus approach to expose the knee joint.

  • medial parapatellarProcedure or surgery

    Patients receive total knee arthroplasty with medial parapatellar approach to expose the knee joint

Study groups in NCT07742696
Study groupRoleWhat they receive
subvastus approachExperimentalPatients receive total knee arthroplasty with subvastus approach.
Receives: Procedure: subvastus
medial parapatellar approachActive comparatorPatients receive total knee arthroplasty with medial parapatellar approach, which is classic, mature and with exact curative effect.
Receives: Procedure: medial parapatellar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    The higher the score, the more severe the symptoms and the worse the postoperative functional recovery.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  2. Knee Society Score(KSS)

    The lower the score, the more severe the symptoms and the worse the postoperative functional recovery.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  3. Short Form 12 Health Survey Questionnaire(SF-12)

    The higher score equals to the better postoperative satisfaction.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  4. First Unassisted Straight Leg Raise(SLR)

    Record the time of the first postoperative unassisted straight leg raise of every patient.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

Secondary outcomes (4)

  1. Range of Motion of Knee Joint(ROM)

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  2. Visual Analogue Scale(VAS)

    The higher the score, the stronger the patient's subjective pain perception.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  3. Myodynamia of Quadriceps Femoris

    Surgeons will measure the patients' muscle strength of Quadriceps Femoris using manual muscle testing, based on Lovett Scale for Muscle Strength Assessment.

    Measured: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty

  4. Shear Wave Elastography of Quadriceps Femoris

    SWE displays the strength and hardness with precise values.

    Measured: 3 months after receiving total knee arthroplasty

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start15 Jul 2026 (estimated)
  3. Primary completion15 Feb 2027 (estimated)
  4. Study completion15 Jul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07742696
Sponsor's protocol ID
PUTH00238
Status last verified
Jun 2026
First submitted
6 Jul 2026
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aladraii AA, Allehaibi LZ, Fattani AA, Alkhudairy TA, Al-Margan AM, Al-Dubai SAR, Mohammed AA, Mohorjy DK, Alqarni AS. Functional Outcome of Subvastus versus Medial Parapatellar Approaches for Total Knee Replacement in Patients with Knee Osteoarthritis: A Prospective Cohort Study. Saudi J Med Med Sci. 2024 Jan-Mar;12(1):35-39. doi: 10.4103/sjmms.sjmms_237_23. Epub 2024 Jan 15.

    PubMed 38362087

  • Migliorini F, Aretini P, Driessen A, El Mansy Y, Quack V, Tingart M, Eschweiler J. Better outcomes after mini-subvastus approach for primary total knee arthroplasty: a Bayesian network meta-analysis. Eur J Orthop Surg Traumatol. 2020 Aug;30(6):979-992. doi: 10.1007/s00590-020-02648-9. Epub 2020 Mar 10.

    PubMed 32152747

  • Khan MNH, Abbas K, Faraz A, Ilyas MW, Shafique H, Jamshed MH, Hashmi P. Total knee replacement: A comparison of the subvastus and medial parapatellar approaches. Ann Med Surg (Lond). 2021 Aug 8;68:102670. doi: 10.1016/j.amsu.2021.102670. eCollection 2021 Aug.

    PubMed 34408867

  • Wu Y, Zeng Y, Bao X, Xiong H, Hu Q, Li M, Shen B. Comparison of mini-subvastus approach versus medial parapatellar approach in primary total knee arthroplasty. Int J Surg. 2018 Sep;57:15-21. doi: 10.1016/j.ijsu.2018.07.007. Epub 2018 Jul 26.

    PubMed 30056128

  • Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.

    PubMed 28844632

  • Hosseini-Monfared P, Mirahmadi A, Amiri S, Minaie R, Ghafouri MH, Kazemi SM. Comparable long-term functional outcomes of subvastus and medial parapatellar approach in total knee arthroplasty: A 10-year follow-up study. J Exp Orthop. 2024 Oct 8;11(4):e70035. doi: 10.1002/jeo2.70035. eCollection 2024 Oct.

    PubMed 39380847

  • Mahmoudian A, Lohmander LS, Mobasheri A, Englund M, Luyten FP. Early-stage symptomatic osteoarthritis of the knee - time for action. Nat Rev Rheumatol. 2021 Oct;17(10):621-632. doi: 10.1038/s41584-021-00673-4. Epub 2021 Aug 31.

    PubMed 34465902

Questions about this trial

What is this clinical trial studying?

A study testing subvastus and medial parapatellar in people with Osteoarthritis (OA) of the Knee, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ran Zhao, MD (+8613161866294, 2411210441@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) (time frame: From enrollment to the end of follow-up at 2 years after receiving total knee arthroplasty). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742696, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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