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Cartilage DamageNCT06644092

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

A study testing Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation in people with Cartilage Damage and Osteochondral Lesion, run by Yeditepe University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cartilage Damage, Osteochondral Lesion, Allograft
What is being tested?
Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Oct 2024to 9 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Yeditepe University Hospital

    Istanbul, Atasehir, 34000

Other trials in Turkey (Türkiye)

About this study

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.

Being tested
Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation
Keywords
Physical Therapy, Osteochondral Allograft Transplantation, Osteochondral Lesion, Cartilage Damage
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation OperationOther

    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.

Study groups in NCT06644092
Study groupRoleWhat they receive
Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral AllograftExperimentalThe 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.
Receives: Other: Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. KOOS

    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.

    Measured: 6 months

  2. Oxford Knee Scale

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start9 Oct 2024
  3. Primary completion9 Apr 2025 (estimated)
  4. Study completion9 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644092
Sponsor's protocol ID
YagmurOrta
Status last verified
Oct 2024
First submitted
10 Oct 2024
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Investigation of the Effectiveness of Physiotherapy and Rehabilitation After Osteochondral Allograft Transplantation Operation in people with Cartilage Damage and Osteochondral Lesion, run by Yeditepe University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

KOOS (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644092, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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