Manual Traction and Rehabilitation After Knee Replacement Surgery

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)

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 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.

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.

Sponsors & Collaborators

• University Clinical Centre of Kosova

  collaborator OTHER

• Royal Medical Hospital LLC.

  collaborator UNKNOWN

• Alma Mater Europaea - Slovenia

  lead OTHER

Principal Investigators

• MIMOZE ZOGAJ, MSc · Alma Mater Europaea - Slovenia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-22

Primary Completion

2026-10-22

Completion

2026-11-12

Countries

• Kosovo

Study Locations