Manual Traction and Rehabilitation After Knee Replacement Surgery

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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
• 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.

Primary outcome measures

• Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS) [Time frame: Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).]

Secondary outcome measures (8)

• Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR) [Time frame: Pre-treatment and at the fourth postoperative week.]
• Knee range of motion [Time frame: Baseline (preoperative), pre-treatment, and at the fourth postoperative week.]
• Timed Up and Go Test (TUG) [Time frame: At the fourth postoperative week.]
• Joint Perception Measured by the Forgotten Joint Score-12 (FJS-12) [Time frame: At 4 weeks after surgery.]
• Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) [Time frame: Before surgery (baseline) and at 4 weeks after surgery.]
• Two-Minute Walk Test (2MWT) [Time frame: At 4 weeks after surgery.]
• Single-Leg Stance Test (SLST) [Time frame: At 4 weeks after surgery.]
• Five Times Sit-to-Stand Test (5xSTS) [Time frame: At 4 weeks after surgery.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Kosovo · 1 center

• University Clinical Center of Kosovo (UCCK) - Clinic of Physical Medicine and Rehabilitati — Pristina

Identifiers

NCT: NCT07722559 · SMART-TKA-281

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗