An interventional study of Accelerated rehabilitation protocol and Conservative rehabilitation protocol in Patella Alta, Tibial Tubercle Distalisation Osteotomy and Rehabilitation, sponsored by Tampere University Hospital. Status unknown. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Tampere University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to compare in distalising tibial tubercle osteotomy procedure group fast rehabilitation to traditional rehabilitation.
The main questions it aims to answer are:
Participants will be following fast rehabilitation or the traditional rehabilitation guidelines after distalising tibial tubercle osteotomy procedure according to the randomisation.
Researchers will compare fast rehabilitation group to the traditional rehabilitation group to see if recovery and functional outcome is improved in fast rehabilitation group and complication rate will be similar in both groups.
Patella alta is a clinical condition where the patella is positioned too proximal in relation to the femoral trochlea. Such an abnormality may cause patellar instability and predispose to recurrent patellofemoral dislocations and patellofemoral pain. There are no conclusive guidelines for determining a threshold for too high positioned patella, as several different methods have been described to measure patellar height. As a surgical solution, distalising tibial tubercle osteotomy has been described to correct excessive patellar height.
In the early phase of the distalising tibial tubercle osteotomy postoperative protocol, weightbearing and knee flexion are limited with a brace commonly for 4-8 weeks. The potential risks for adverse effects associated with the limitation rehabilitation protocol include a delay in regaining knee range of motion, stiffness and muscle weakness. As a result, recovery from surgery is delayed and may lead to additional procedures and long-term morbidity in knee function.
This is a prospective, randomised, controlled, single-blinded, single centre trial comparing a novel accelerated rehabilitation protocol with the traditional, motion restricting rehabilitation protocol. All skeletally mature patients aged 35 years and younger, referred to as the distalising tibial tubercle osteotomy procedure group, are eligible for inclusion in the study. Patients will be randomised to either the fast rehabilitation group or the traditional rehabilitation group. Patients with patellar instability will be additionally treated with medial patellofemoral ligament reconstruction.
The hypothesis of the trial is that the novel accelerated rehabilitation protocol will lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol. A secondary hypothesis is that the complication rate will be similar in both groups.
The study will document short-term recovery and the planned follow-up will be 3 years. After the 1-year follow-up, the trial results will be disseminated in a major peer-reviewed orthopaedic publication.
Tampere University Hospital is the lead sponsor of 211 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Radiographic:
General:
Those patients who decline to take part in the trial will be asked to join a follow-up cohort as a background population. The patients in this follow-up cohort will be treated "as normal" without allocation, but the follow-up questionnaires will be the same as those given to the randomly assigned population. The patients in the follow-up cohort will also be asked to provide informed written consent.
Elements of physical therapy Group 1 Accelerated rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations No Weight-bearing limitations No, crutches are recommended for 4 weeks. Active exercises. Functional exercises. 1 week Active dynamic strengthening exercises. 5 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks
Procedure: Accelerated rehabilitation protocol
Elements of physical therapy Group 2 Conservative rehabilitation Antioedema knee, calf, leg Day 1 Knee brace, ROM limitations 6 weeks Weight-bearing limitations 4 weeks limb weight, followed by half body weight till week 6 Active exercises. Functional exercises. 8 weeks Active dynamic strengthening exercises. 8 weeks Closed chain exercises for muscle strengthening. 8 weeks Muscle endurance and neuromuscular control, progress strengthening exercises, jogging 12 weeks
Procedure: Conservative rehabilitation protocol
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The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.
A difference of 10º in full range of movement will be considered significant. The results will be measured with a long goniometer in a standardised manner.
Time frame: At 12 weeks
Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).
KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living, Function in sport and recreation and knee related Quality of life. The baseline score from KOOS is recorded during the physiotherapist visit.
Time frame: measured at baseline, 6, 24 and 52 weeks postoperatively
No study locations are listed for this record.
Plan to share: No — The copyright of the trial research data will be owned and created by the participating research parties. The data will be shared among all participating researchers who will receive access to the data after the trial is completed. Due to confidentiality and legal agreements, public data sharing will be restricted because we only have permission to hold the data in the specific research server, not to transfer data. Under certain circumstances, for example, when a new member joins the collaboration, we will grant access to the data.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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