Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Manual Traction and Rehabilitation After Knee Replacement Surgery (SMART-TKA)

21. juli 2026 opdateret af: Mimozë Zogaj, Alma Mater Europaea - Slovenia

The Short-Term Impact of Manual Traction Combined With Standard Rehabilitation Protocol on Pain, Function, and Quality of Life After Total Knee Arthroplasty

The goal of this clinical trial is to determine whether the addition of manual traction to a standard rehabilitation protocol improves early recovery after primary total knee arthroplasty (TKA) in women aged 50-75 years with knee osteoarthritis.

The main questions it aims to answer are:

  • Does the addition of manual traction reduce postoperative pain during the first four weeks after TKA?
  • Does manual traction improve physical function, knee range of motion, patient-reported knee function, and health-related quality of life compared with standard rehabilitation alone?
  • Does manual traction reduce the need for analgesic medication during the early postoperative rehabilitation period?

Researchers will compare participants receiving manual traction plus standard rehabilitation with participants receiving sham traction plus the same standard rehabilitation protocol to determine whether manual traction provides additional clinical benefits during early rehabilitation after TKA.

Participants will:

  • Be randomly assigned to either the manual traction group or the sham traction (control) group.
  • Receive a standardized rehabilitation program for four weeks after surgery, with the intervention group receiving manual traction and the control group receiving sham traction.
  • Attend supervised rehabilitation sessions five times per week throughout the four-week intervention period.
  • Complete validated questionnaires assessing pain, knee function, joint awareness, and health-related quality of life at predefined assessment time points.
  • Undergo standardized clinical assessments of knee range of motion and physical function before surgery, before rehabilitation, during follow-up, and one month after surgery.
  • Have their analgesic medication use recorded throughout the rehabilitation period.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Total knee arthroplasty (TKA) is one of the most effective surgical procedures for managing end-stage knee osteoarthritis. Despite advances in surgical techniques and postoperative care, many patients continue to experience pain, reduced range of motion, impaired physical function, and delayed recovery during the early postoperative period. Early rehabilitation is therefore essential to optimize functional outcomes, promote independence, and improve health-related quality of life.

Standard rehabilitation following TKA typically includes pain management, therapeutic exercises, gait training, progressive weight-bearing, and functional mobility training. Although these interventions are effective, additional manual therapy techniques may further enhance postoperative recovery by reducing pain, improving joint mobility, and facilitating functional performance.

Manual traction is a passive joint distraction technique designed to decrease compressive forces across the tibiofemoral joint, improve joint mobility, and reduce pain. While manual traction has demonstrated beneficial effects in patients with knee osteoarthritis and other musculoskeletal disorders, evidence regarding its effectiveness during the early rehabilitation period after TKA remains limited. High-quality randomized controlled trials investigating this intervention in the postoperative setting are scarce.

This randomized, double-blind, sham-controlled clinical trial aims to evaluate the effectiveness of adding manual traction to a standardized rehabilitation protocol during the first four postoperative weeks following primary TKA. Participants will be randomly allocated to receive either manual traction combined with standard rehabilitation or sham traction combined with the same rehabilitation program. Participant and outcome assessor blinding will be implemented to minimize performance and assessment bias, while the treating physiotherapist will not participate in outcome assessment because blinding of the therapist is not feasible.

Detailed Description - The study is designed to determine whether the addition of manual traction provides clinically meaningful improvements during early postoperative recovery. The findings are expected to provide evidence regarding the effectiveness of manual traction as an adjunct to standard rehabilitation and may contribute to the optimization of postoperative physiotherapy protocols following primary total knee arthroplasty.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kosovo
    • Pristina District
      • Pristina, Pristina District, Kosovo, 10000
        • University Clinical Center of Kosovo (UCCK) - Clinic of Physical Medicine and Rehabilitation
        • Kontakt:
        • Ledende efterforsker:
          • MIMOZE ZOGAJ, MSc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Female patients aged between 50 and 75 years.
  • Patients who will undergo primary total knee arthroplasty due to osteoarthritis, classified as Kellgren-Lawrence grades 3 to 4.
  • Patients willing to participate in the study and able to provide informed consent.

Exclusion Criteria:

  • Morbid obesity, defined as a body mass index (BMI) greater than 40 kg/m².
  • Revision arthroplasty procedures.
  • Presence of severe cardiac, vascular, renal, neurological, psychiatric, or other orthopedic conditions affecting the lower limb and limiting functional abilities.
  • Active infections or contraindications to physical therapy.
  • Inability to comply with the prescribed rehabilitation protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Traction Group (TG)
Participants assigned to this arm will receive manual tibiofemoral traction combined with a standardized rehabilitation program following total knee arthroplasty. Manual traction will be applied by a licensed physiotherapist using the Kaltenborn mobilization technique for three weeks, with progressive traction grades and force adjusted according to the study protocol and patient tolerance. The standardized rehabilitation program will include supervised therapeutic exercises targeting pain reduction, improvement of knee range of motion, muscle strength, functional mobility, gait, and overall postoperative recovery.
Procedure: Manual Tibiofemoral Traction
Participants will receive manual tibiofemoral traction combined with a standardized rehabilitation program following total knee arthroplasty. During the first postoperative week, all participants will receive standard rehabilitation without traction. Manual traction will begin in the second postoperative week and will be applied by a physiotherapist using the Kaltenborn technique. The distal femur will be stabilized with a fixation belt, while a separate traction belt around the distal tibia and fibula will apply tibiofemoral traction with the knee in extension. Traction will progress over three weeks: Grade I in week 2 (10-15% body weight), Grade II in week 3 (15-20%), and Grade III in week 4 (20-25%). The traction grade and force will be adjusted according to patient tolerance and postoperative safety. Each session will include 30-60 seconds of traction followed by a 15-second rest interval, repeated for eight cycles. After each session, ROM (20 active,20 assisted) will be performed.
Sham-komparator: Control Group (CG)
Participants assigned to this arm will receive sham tibiofemoral traction combined with the same standardized rehabilitation program following total knee arthroplasty. Sham traction will replicate the positioning and therapist contact of the manual traction procedure without the application of therapeutic traction force, in order to maintain participant blinding. The standardized rehabilitation program will include supervised therapeutic exercises identical to those provided to the intervention group, targeting pain management, knee range of motion, muscle strength, functional mobility, gait, and postoperative recovery.
Procedure: Sham Tibiofemoral Traction
Participants assigned to the control group will receive sham tibiofemoral traction combined with the standardized rehabilitation program following total knee arthroplasty. Sham traction will simulate the manual traction procedure without the application of therapeutic traction force. The procedure will be performed to maintain participant blinding while providing the same rehabilitation protocol as the intervention group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Tidsramme: Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.
Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
Tidsramme: Pre-treatment and at the fourth postoperative week.
Physical function will be assessed using the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR), a 7-item questionnaire. The raw score (0-28) is converted to a normalized score ranging from 0 to 100, where 0 indicates extreme knee-related problems and 100 indicates optimal knee health. Higher scores indicate better knee function.
Pre-treatment and at the fourth postoperative week.
Knee range of motion
Tidsramme: Baseline (preoperative), pre-treatment, and at the fourth postoperative week.
Knee range of motion will be measured in degrees using a universal goniometer. Higher values indicate greater knee joint mobility and better functional outcome.
Baseline (preoperative), pre-treatment, and at the fourth postoperative week.
Timed Up and Go Test (TUG)
Tidsramme: At the fourth postoperative week.
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Lower times indicate better functional mobility.
At the fourth postoperative week.
Joint Perception Measured by the Forgotten Joint Score-12 (FJS-12)
Tidsramme: At 4 weeks after surgery.
Joint perception will be assessed using the Forgotten Joint Score-12 (FJS-12), a 12-item questionnaire. Raw scores are converted to a 0-100 scale, where 0 indicates the greatest joint awareness and 100 indicates complete joint awareness forgetting. Higher scores indicate better joint perception and less awareness of the operated knee during daily activities.
At 4 weeks after surgery.
Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Tidsramme: Before surgery (baseline) and at 4 weeks after surgery.
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L). The questionnaire evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ Visual Analogue Scale (EQ-VAS) ranges from 0 to 100, where 0 indicates the worst imaginable health state and 100 indicates the best imaginable health state. Higher scores indicate better health-related quality of life.
Before surgery (baseline) and at 4 weeks after surgery.
Two-Minute Walk Test (2MWT)
Tidsramme: At 4 weeks after surgery.
Functional walking capacity will be assessed using the Two-Minute Walk Test (2MWT). The total distance walked in 2 minutes will be recorded in meters. Higher distances indicate better walking capacity.
At 4 weeks after surgery.
Single-Leg Stance Test (SLST)
Tidsramme: At 4 weeks after surgery.
Balance will be assessed using the Single-Leg Stance Test (SLST). The duration participants are able to maintain single-leg stance will be recorded in seconds. Longer times indicate better balance.
At 4 weeks after surgery.
Five Times Sit-to-Stand Test (5xSTS)
Tidsramme: At 4 weeks after surgery.
Lower limb functional performance will be assessed using the Five Times Sit-to-Stand Test (5xSTS). The time required to complete five consecutive sit-to-stand repetitions will be recorded in seconds. Lower times indicate better lower limb functional performance.
At 4 weeks after surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alma Mater Europaea - Slovenia

Samarbejdspartnere

University Clinical Centre of Kosova
Royal Medical Hospital LLC.

Efterforskere

  • Ledende efterforsker: MIMOZE ZOGAJ, MSc, Alma Mater Europaea - Slovenia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

22. juli 2026

Primær færdiggørelse (Anslået)

22. oktober 2026

Studieafslutning (Anslået)

12. november 2026

Datoer for studieregistrering

Først indsendt

16. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SMART-TKA-281

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because the study involves identifiable clinical data collected from human participants. Data will be protected to ensure participant confidentiality and privacy in accordance with ethical approval requirements and applicable data protection regulations. Only aggregated, de-identified study results will be reported in scientific publications.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Total knæarthroplastik (TKA)

Kliniske forsøg med Manual Tibiofemoral Traction

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Greece

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner