Manual Traction and Rehabilitation After Knee Replacement Surgery

NCT07722559 | Not Yet Recruiting

• 1 other identifier: SMART-TKA-281
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis (OA); Total Knee Arthroplasty (TKA)

Keywords

Manual Traction; Quality of life; Early rehabilitation; Standard Rehabilitation protocol; Total Knee Arthroplasty; Pain; Function

Outcome Measures

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.

  Baseline (preoperative) and weekly during the first four postoperative weeks (5 assessments).

Secondary Outcomes (8)

• Physical Function Measured by the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

  Pre-treatment and at the fourth postoperative week.

• Knee range of motion

  Baseline (preoperative), pre-treatment, and at the fourth postoperative week.

• Timed Up and Go Test (TUG)

  At the fourth postoperative week.

• Joint Perception Measured by the Forgotten Joint Score-12 (FJS-12)

  At 4 weeks after surgery.

• Health-Related Quality of Life Measured by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

  Before surgery (baseline) and at 4 weeks after surgery.

Study Arms (2)

Traction Group (TG)

EXPERIMENTAL

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.

Procedure: Manual Tibiofemoral Traction

Control Group (CG)

SHAM COMPARATOR

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.

Procedure: Sham Tibiofemoral Traction

Interventions

Manual Tibiofemoral Traction PROCEDURE

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.

Traction Group (TG)

Sham Tibiofemoral Traction PROCEDURE

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.

Control Group (CG)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alma Mater Europaea - Slovenia: lead
• University Clinical Centre of Kosova: collaborator
• Royal Medical Hospital LLC.: collaborator

Study Sites (1)

University Clinical Center of Kosovo (UCCK) - Clinic of Physical Medicine and Rehabilitation

Pristina, Pristina District, 10000, Kosovo

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MIMOZE ZOGAJ, MSc

  Alma Mater Europaea - Slovenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MIMOZE ZOGAJ, MSc

CONTACT

+38344795907; mimoze.zogaj1@almamater.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. Participant blinding will be maintained through the use of sham traction in the control group. Due to the nature of the intervention, the treating physiotherapist cannot be blinded and will not be involved in outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive manual tibiofemoral traction combined with a standardized rehabilitation protocol, while the control group will receive sham traction combined with the same standardized rehabilitation protocol. Participants and outcome assessors will be blinded to group allocation; however, the treating physiotherapist cannot be blinded due to the nature of the intervention. The intervention will be administered over a three-week period, and outcomes will be assessed according to the predefined study schedule.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 23, 2026
• Study Start: July 22, 2026
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): November 12, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KO (1)