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NCT07722559
Manual Traction and Rehabilitation After Knee Replacement Surgery
Conditions: Knee Osteoarthritis (OA), Total Knee Arthroplasty (TKA)
Sex: Female
Ages: 50 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Alma Mater Europaea - Slovenia
Location: University Clinical Center of Kosovo (UCCK) - Clinic of Physical Medicine and Rehabilitation Pristina Pristina District
Summary
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
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.
Source: ClinicalTrials.gov (NCT07722559). StuddyBuddy aggregates publicly available trial information.