Clinical trial NCT05854056: Tibial Tubercle Distalisation and Accelerated Rehabilitation
Official title: Effect of Accelerated Postoperative Rehabilitation After Tibial Tubercle Distalisation: a Randomised Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patella Alta
Tibial Tubercle Distalisation Osteotomy
Rehabilitation
Keywords: Patella Alta
Tibial tubercle distalisation osteotomy
Accelerated rehabilitation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Pihlajalinna Hospital, Tampere
First posted: 2023-05-11
Enrollment: 144
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* Will the novel accelerated rehabilitation protocol lead to faster recovery and improved functional outcome at 6, 12 and 24 weeks compared with the conservative rehabilitation protocol?
* Will the complication rate be similar in both groups?

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Symptomatic patella alta with recurrent dislocation or subluxation. Long-lasting anterior knee pain not responding to rehabilitation.

Exclusion Criteria:

Radiographic:

* Open growth plates
* Iwano \[8\] grade III and IV changes in patellofemoral joint
* Caton-Deschamps \<1.1 in MRI
* PTI \>50% in MRI
* High grade trochlear dysplasia

General:

* Refuses to participate in the study
* Aged less than 15 or more than 35 years
* Severe neurological, pulmonal or cardiovascular comorbidities that are contraindications for surgery
* Lack of adequate co-operation
* Does not adequately understand written and spoken instructions in the local language

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.

Primary outcomes:
measure: The primary outcome in this study will be knee range of motion (ROM) measured at 12 weeks postoperatively.
timeFrame: At 12 weeks
Secondary outcomes:
measure: Secondary outcomes will be knee the Knee Injury and Osteoarthritis Outcome Score (KOOS).
timeFrame: measured at baseline, 6, 24 and 52 weeks postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Pihlajalinna
name: Frederick Weitz
role: STUDY_CHAIR
affiliation: Department of Orthopaedic Surgery, Tampere University Hospital, Tampere, Finland
name: Ville M Mattila, Prof
role: STUDY_CHAIR
affiliation: Pihlajalinna
name: Erkki Nilkku
role: STUDY_CHAIR
affiliation: Pihlajalinna
name: Petri J Sillanpää
role: STUDY_CHAIR
References:
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citation: Caton J, Mironneau A, Walch G, Levigne C, Michel CR. [Idiopathic high patella in adolescents. Apropos of 61 surgical cases]. Rev Chir Orthop Reparatrice Appar Mot. 1990;76(4):253-60. French.
citation: Sherman SL, Erickson BJ, Cvetanovich GL, Chalmers PN, Farr J 2nd, Bach BR Jr, Cole BJ. Tibial Tuberosity Osteotomy: Indications, Techniques, and Outcomes. Am J Sports Med. 2014 Aug;42(8):2006-17. doi: 10.1177/0363546513507423. Epub 2013 Nov 6.
citation: Ambra LF, Phan A, Gomoll AH. A New Technique for Distalization of the Tibial Tubercle That Allows Preservation of the Proximal Buttress. Orthop J Sports Med. 2018 Sep 25;6(9):2325967118798621. doi: 10.1177/2325967118798621. eCollection 2018 Sep.
citation: Mansourvar M, Ismail MA, Raj RG, Kareem SA, Aik S, Gunalan R, Antony CD. The applicability of Greulich and Pyle atlas to assess skeletal age for four ethnic groups. J Forensic Leg Med. 2014 Feb;22:26-9. doi: 10.1016/j.jflm.2013.11.011. Epub 2013 Dec 3.
citation: Iwano T, Kurosawa H, Tokuyama H, Hoshikawa Y. Roentgenographic and clinical findings of patellofemoral osteoarthrosis. With special reference to its relationship to femorotibial osteoarthrosis and etiologic factors. Clin Orthop Relat Res. 1990 Mar;(252):190-7.
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