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

21 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Kosovo
    • Pristina District
      • Pristina, Pristina District, Kosovo, 10000
        • University Clinical Center of Kosovo (UCCK) - Clinic of Physical Medicine and Rehabilitation
        • Contatto:
        • Investigatore principale:
          • MIMOZE ZOGAJ, MSc

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Comparatore fittizio: 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.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alma Mater Europaea - Slovenia

Collaboratori

University Clinical Centre of Kosova
Royal Medical Hospital LLC.

Investigatori

  • Investigatore principale: MIMOZE ZOGAJ, MSc, Alma Mater Europaea - Slovenia

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

22 luglio 2026

Completamento primario (Stimato)

22 ottobre 2026

Completamento dello studio (Stimato)

12 novembre 2026

Date di iscrizione allo studio

Primo inviato

16 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • SMART-TKA-281

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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