Manual Traction and Rehabilitation After Knee Replacement Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50-75
SponsorAlma Mater Europaea - Slovenia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manual Tibiofemoral Traction
Procedure/SurgeryParticipants 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 Tibiofemoral Traction
Procedure/SurgeryParticipants 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.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Traction Group (TG)Experimental treatment 1 intervention
Group B: Control Group (CG)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
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.
Time frame
Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).Secondary outcomes
1
Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)
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.
Time frame
Pre-treatment and at the fourth postoperative week.2
Knee range of motion
Knee range of motion will be measured in degrees using a universal goniometer. Higher values indicate greater knee joint mobility and better functional outcome.
Time frame
Baseline (preoperative), pre-treatment, and at the fourth postoperative week.3
Timed Up and Go Test (TUG)
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.
Time frame
At the fourth postoperative week.4
Joint Perception Measured by the Forgotten Joint Score-12 (FJS-12)
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.
Time frame
At 4 weeks after surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Alma Mater Europaea - Slovenia
Lead sponsor
University Clinical Centre of Kosova
Collaborator
Royal Medical Hospital LLC.
Collaborator
Source ClinicalTrials.gov
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