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

21. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

48

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Postup: 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.
Falešný srovnávač: 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.
Postup: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alma Mater Europaea - Slovenia

Spolupracovníci

University Clinical Centre of Kosova
Royal Medical Hospital LLC.

Vyšetřovatelé

  • Vrchní vyšetřovatel: MIMOZE ZOGAJ, MSc, Alma Mater Europaea - Slovenia

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

22. července 2026

Primární dokončení (Odhadovaný)

22. října 2026

Dokončení studie (Odhadovaný)

12. listopadu 2026

Termíny zápisu do studia

První předloženo

16. července 2026

První předloženo, které splnilo kritéria kontroly kvality

21. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

21. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • SMART-TKA-281

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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