- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07688642
Circulatory Exercise After Total Knee Replacement
Boosting Venous Return After Knee Replacement: Effects of a Novel Circulatory Exercise on Early Postoperative Inflammation - A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adults ≥ 18 years undergoing elective unilateral primary TKR for osteoarthritis.
- Able to provide informed consent.
- Able to perform the exercise (cognitively and physically) prior to discharge.
Exclusion Criteria:
- Preexisting peripheral vascular disease with severe ischemia or venous insufficiency that limits exercise.
- Contraindication to early active movement per surgeon (e.g., complex surgical fixation limiting motion if present).
- Severe neurological or cognitive impairment preventing instruction adherence.
- Inability to comply with follow-up.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: standard postoperative TKR rehabilitation (hospital protocol)
|
Participants will receive standard postoperative total knee replacement rehabilitation according to the local hospital protocol, including early mobilization, ROM exercises, quadriceps activation, ambulation training, and standard pain/edema management as clinically indicated.
|
|
Sperimentale: Circulatory Exercise Protocol (in addition to standard rehab)
|
Participants will receive standard postoperative rehabilitation plus a circulatory exercise protocol including supine leg elevation with ankle pump and knee extension, and seated knee extension with alternating ankle dorsiflexion.
The exercise will be performed at approximately 15 cycles/minute, 10 sets of 1 minute, 60 seconds rest between sets, twice daily for 14 postoperative days.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Difference in postoperative lower-limb edema between the operated and contralateral limbs measured by standardized limb circumference (cm)
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Lower-limb circumference (cm) will be measured bilaterally at standardized anatomical landmarks: 10 cm above the superior border of the patella, at the mid-patellar level, and 20 cm above the superior border of the patella.
Measurements will be obtained on both the postoperative limb and the contralateral (sound) limb.
Edema will be quantified as the side-to-side difference in circumference and the change from baseline.
|
Baseline/preoperative to postoperative day 14
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Postoperative pain intensity measured by the Numeric Rating Scale (NRS, 0-10) at rest and during activity
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Scores will be recorded at rest and during activity.
|
Baseline/preoperative to postoperative day 14
|
|
Functional mobility:
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Timed Up and Go (TUG) (go for 3 meter and come back). Record assistance level and gait aids. 3-meter walk test at regular base and fast base. |
Baseline/preoperative to postoperative day 14
|
|
Analgesic consumption
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Opioid consumption: record rescue analgesic use
|
Baseline/preoperative to postoperative day 14
|
|
Quadriceps strength via handheld dynamometry.
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Seated 60 Degrees Knee Flexion Patient position Seated on the edge of the table, with feet not in contact with the ground and knee at 60 degrees of flexion. Contact point Posterior aspect of the ankle attachment, at the hook closest to the achilles tendon. Device orientation Horizontal, linked to the ankle strap at one end and anchored to a fixed surface by the cable strap at the other, posterior to the patient's leg being tested. Position of examiner Adjacent to the patient, in a position to situate the DynaMo and instruct the action. Instruction Pull against the DynaMo as hard as you can. 3, 2, 1 - pull, pull, pull and relax. Attachments Tension links, Carabiners, Ankle strap, Tension strap. |
Baseline/preoperative to postoperative day 14
|
|
Neuromuscular electrical stimulation response
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
Neuromuscular electrical stimulation response by chattanoga multi-current electrical stimulation.
|
Baseline/preoperative to postoperative day 14
|
|
Patient satisfaction with postoperative recovery measured by a 5-point Likert Scale
Lasso di tempo: postoperative day 14
|
Patient satisfaction with postoperative recovery will be assessed on postoperative day 14 using a 5-point Likert Scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied.
|
postoperative day 14
|
|
Serum Interleukin-6 (IL-6)
Lasso di tempo: Baseline (pre-operative), 24-48 hours post-operative (peak IL-6 window), Baseline/preoperative to postoperative day 14.
|
Interleukin-6 is a pro-inflammatory cytokine and an early mediator of the surgical stress response. Serum IL-6 will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater systemic inflammatory response; IL-6 peaks at approximately 24-48 hours postoperatively. Unit: pg/mL · Reference: < 7 pg/mL (assay-dependent) |
Baseline (pre-operative), 24-48 hours post-operative (peak IL-6 window), Baseline/preoperative to postoperative day 14.
|
|
Hemostasis or clotting tests
Lasso di tempo: Baseline/preoperative to postoperative day 14
|
PT (Prothrombin Time) APTT (Activated Partial Thromboplastin Time) D-dimer Fibrinogen
|
Baseline/preoperative to postoperative day 14
|
|
Serum C-Reactive Protein (CRP)
Lasso di tempo: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
C-reactive protein is a hepatically synthesized acute-phase reactant produced in response to IL-6 signaling. Serum CRP will be measured from peripheral venous blood by immunoturbidimetric assay. Higher concentrations indicate greater systemic inflammation; CRP peaks later than IL-6 (~48-72 hours). Unit: mg/L · Reference: < 10 mg/L (hs-CRP: < 1 low, 1-3 moderate, > 3 high cardiovascular risk) |
Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
|
Serum Interleukin-10 (IL-10)
Lasso di tempo: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
Interleukin-10 is an anti-inflammatory cytokine mediating the compensatory anti-inflammatory response to surgical injury. Serum IL-10 will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater compensatory anti-inflammatory response. Unit: pg/mL · Reference: < 10 pg/mL (often < 5 pg/mL; assay-dependent) |
Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
|
Serum Tumor Necrosis Factor-alpha (TNF-α)
Lasso di tempo: Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
Tumor necrosis factor-alpha is a pro-inflammatory cytokine released early in the innate immune response to tissue injury. Serum TNF-α will be quantified from peripheral venous blood by ELISA. Higher concentrations indicate a greater pro-inflammatory response. Unit: pg/mL · Reference: < 8.1 pg/mL (commonly < 15-20 pg/mL; assay-dependent) |
Baseline (preoperative), postoperative 24-48 hours, and postoperative day 14.
|
|
Prothrombin Time (PT)
Lasso di tempo: Baseline (preoperative) and postoperative day 14.
|
Prothrombin time assesses the extrinsic and common coagulation pathways. PT will be determined on platelet-poor plasma (peripheral venous blood in 3.2% sodium citrate) by an automated clot-based method using a thromboplastin reagent. A prolonged PT indicates impaired extrinsic/common-pathway function. Unit: seconds · Reference: 11-13.5 seconds (INR 0.8-1.1) |
Baseline (preoperative) and postoperative day 14.
|
|
Activated Partial Thromboplastin Time (APTT)
Lasso di tempo: Baseline (preoperative) and postoperative day 14.
|
Activated partial thromboplastin time assesses the intrinsic and common coagulation pathways. APTT will be determined on citrated platelet-poor plasma by an automated clot-based method. A prolonged APTT indicates impaired intrinsic/common-pathway function. Unit: seconds · Reference: 25-35 seconds |
Baseline (preoperative) and postoperative day 14.
|
|
D-dimer
Lasso di tempo: Frame: Baseline (preoperative) and postoperative day 14.
|
D-dimer is a fibrin degradation product reflecting activation of coagulation and fibrinolysis. D-dimer will be measured on citrated plasma by a latex-enhanced immunoturbidimetric assay. Elevated concentrations indicate increased fibrin turnover (hypercoagulable/prothrombotic state or venous thromboembolism). Unit: µg/mL FEU · Reference: < 0.50 µg/mL FEU (< 500 ng/mL FEU) |
Frame: Baseline (preoperative) and postoperative day 14.
|
|
Fibrinogen
Lasso di tempo: Baseline (preoperative) and postoperative day 14.
|
Fibrinogen (coagulation factor I) is the soluble precursor of fibrin and an acute-phase reactant. Plasma fibrinogen will be measured on citrated plasma by the Clauss clot-based method. Elevated concentrations reflect an acute-phase/inflammatory response; low concentrations may reflect consumption or dilution and a bleeding tendency. Unit: mg/dL · Reference: 200-400 mg/dL (2-4 g/L) |
Baseline (preoperative) and postoperative day 14.
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Huang ZY, Huang Q, Wang LY, Lei YT, Xu H, Shen B, Pei FX. Normal trajectory of Interleukin-6 and C-reactive protein in the perioperative period of total knee arthroplasty under an enhanced recovery after surgery scenario. BMC Musculoskelet Disord. 2020 Apr 21;21(1):264. doi: 10.1186/s12891-020-03283-5.
- Si HB, Yang TM, Zeng Y, Zhou ZK, Pei FX, Lu YR, Cheng JQ, Shen B. Correlations between inflammatory cytokines, muscle damage markers and acute postoperative pain following primary total knee arthroplasty. BMC Musculoskelet Disord. 2017 Jun 17;18(1):265. doi: 10.1186/s12891-017-1597-y.
- Windisch C, Kolb W, Kolb K, Grutzner P, Venbrocks R, Anders J. Pneumatic compression with foot pumps facilitates early postoperative mobilisation in total knee arthroplasty. Int Orthop. 2011 Jul;35(7):995-1000. doi: 10.1007/s00264-010-1091-8. Epub 2010 Jul 22.
- Li H, Zhang W, Lu Q, Wang J, Zhi Y, Zhang L, Zhou L. Which Frequency of Ankle Pump Exercise Should Be Chosen for the Prophylaxis of Deep Vein Thrombosis? Inquiry. 2022 Jan-Dec;59:469580221105989. doi: 10.1177/00469580221105989.
- Lee B, Yoon D, Yim J. Effects of an Early Exercise Program with Cryotherapy on Range of Motion, Pain, Swelling, and Gait in Patients with Total Knee Arthroplasty: A Randomized Controlled Trial. J Clin Med. 2024 Feb 29;13(5):1420. doi: 10.3390/jcm13051420.
- Carnevale Pellino V, Gatti A, Vandoni M, Patane P, Febbi M, Ballarin S, Cavallo C, Marin L. Pneumatic Compression Combined with Standard Treatment after Total Hip Arthroplasty and Its Effects on Edema of the Operated Limb and on Physical Outcomes: A Pilot Clinical Randomized Controlled Study. J Clin Med. 2023 Jun 20;12(12):4164. doi: 10.3390/jcm12124164.
- Incesoy MA, Demirkiran CB, Kaya HB, Geckalan MA, Tak AY, Elmali N, Yildiz F, Uzer G. Natural course of postoperative C-reactive protein and erythrocyte sedimentation rate in unilateral and simultaneous bilateral total knee arthroplasty. BMC Musculoskelet Disord. 2025 Mar 14;26(1):260. doi: 10.1186/s12891-025-08523-0.
- Londhe SB, Shah RV, Doshi AP, Londhe SS, Subhedar K. CRP (C Reactive Protein) level after total knee replacement in Indian population--- does it follow Anglo-Saxon trend? Arthroplasty. 2020 Aug 27;2(1):24. doi: 10.1186/s42836-020-00043-7.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 04-2026-30083
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
Prove cliniche su Artrosi al ginocchio
-
University of GroningenCompletato