Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation

October 15, 2024 updated by: YagmurOrta, Yeditepe University
The aim of our study is to add to the literature the effect of the effectiveness of the physiotherapy and rehabilitation in the clinic, which will be applied to the patients after the osteochondral allograft transplantation operation, which is a current treatment approach applied after knee cartilage tissue damage, on the range of motion, functionality, pain and muscle strength of the patients during the recovery process. The clinical importance of our aim is that it will have the potential to guide health professionals in determining the appropriate treatment approach in order to reveal the best results that can be obtained due to the lack of many studies in the literature on the treatment of patients after osteochondral allograft surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atasehir
      • Istanbul, Atasehir, Turkey, 34000
        • Yeditepe University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

Patients who underwent osteochondral allograft transplantation surgery Participant's acceptance/desire to participate in the study

Exclusion criteria:

Patient participant's refusal/desire to participate in the study Inability to perform exercises due to infection etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft

The question of our research is to determine the effectiveness of the physiotherapy and rehabilitation protocol applied in the postoperative period on the knee joint range of motion, functionality, muscle strength around the knee joint (quadriceps/hamstring ratio) and pain parameters in patients who underwent osteochondral allograft transplantation surgery and to include it in the literature. In this direction, the hypotheses of our study are; H0: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery has a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain.

H1: The physical therapy and rehabilitation protocol to be applied after osteochondral allograft transplantation surgery does not have a positive contribution to the patient's knee joint range of motion, functionality, muscle strength and pain.
Other: Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation
The treatment protocol to be applied to the patients after surgery was determined. The protocol includes; cold application, game ready device application, CPM device application, patellar mobilization, soft tissue mobilization application, TENS, conventional TENS and NMES application, ultrasound application, stretching exercises, strengthening exercises, mobilization exercises, balance and proprioception exercises, walking training and kinesio taping.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KOOS
Time Frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS): A health measure used to evaluate knee injuries and knee-related conditions such as osteoarthritis. The KOOS comes in a widely used questionnaire format to assess patients' knee function, pain, quality of life, and other symptoms. By measuring problems in subcategories such as pain, symptoms, quality of life, functional limitations, and sports/dialysis activities, it provides healthcare professionals with an important tool to monitor patients' response to treatment, evaluate treatment plans, and understand patients' quality of life.
6 months
Oxford Knee Scale
Time Frame: 6 months
The Oxford Knee Score (ODS) is a valid and reliable questionnaire with a Turkish version that allows individuals with knee OA to assess their own function and pain. It is scored on a Likert scale from 0 (absent) to 4 (severe) (0-48). In this questionnaire consisting of 12 questions, questions 2, 3, 7, 11 and 12 assess functional status; questions 1, 4, 5, 6, 8, 9 and 10 assess pain-related status. Scores from ODS pain questions range from 0 to 28 points, with the lowest score being 0 and the highest score being 28. Scores from ODS function 30 parameters range from 0 to 20 points, with the lowest score being 0 and the highest score being 20. High scores indicate worse functional status and pain.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yeditepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Nho SJ, Pensak MJ, Seigerman DA, Cole BJ. Rehabilitation after autologous chondrocyte implantation in athletes. Clinics in sports medicine. 2010 Apr 1;29(2):267-82. 2. Flanigan DC, Harris JD, Trinh TQ, Siston RA, Brophy RH. Prevalence of chondral defects in athletes' knees: a systematic review. Med Sci Sports Exerc. 2010 Oct 1;42(10):1795-801. 3. Moyad TF. Cartilage injuries in the adult knee: evaluation and management. Cartilage. 2011 Jul;2(3):226-36. 4. Hjelle K, Solheim E, Strand T, Muri R, Brittberg M. Articular cartilage defects in 1,000 knee arthroscopies. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2002 Sep 1;18(7):730-4. 5. Chimutengwende-Gordon M, Donaldson J, Bentley G. Current solutions for the treatment of chronic articular cartilage defects in the knee. EFORT open reviews. 2020 Mar 2;5(3):156-63. 6. Berta Á, Duska Z, Tóth F, Hangody L. Clinical experiences with cartilage repair techniques: outcomes, indications, contraindications and rehabilitation. Joint Diseases and Related Surgery. 2015;26(2):084-96. 7. Cole BJ, Haunschild ED, Carter T, Meyer J, Fortier LA, Gilat R, ... & Pace JL. Clinically significant outcomes following the treatment of focal cartilage defects of the knee with microfracture augmentation using cartilage allograft extracellular matrix: a multicenter prospective study. Arthroscopy: The Journal of Arthroscopic & Related Surgery. 2021 May;37(5):1512-1521. 8. Vogt S, Angele P, Arnold M, Brehme K, Cotic M, Haasper C, Hinterwimmer S, Imhoff AB, Petersen W, Salzmann G, Steinwachs M. Practice in rehabilitation after cartilage therapy: an expert survey. Archives of orthopaedic and trauma surgery. 2013 Mar;133:311-20. 9. Krych AJ, Saris DB, Stuart MJ, Hacken B. Cartilage injury in the knee: assessment and treatment options. JAAOS-Journal of the American Academy of Orthopaedic Surgeons. 2020 Nov;28(22):914-922. 10. Crowley SG, Pedersen A, Fortney TA, Swindell HW, Saltzman BM, Popkin CA, Trofa DP. Rehabilitation variability fo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2024

Primary Completion (Estimated)

April 9, 2025

Study Completion (Estimated)

May 9, 2025

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YagmurOrta

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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